RTS is a Third Party Review Organization accredited to perform 510(k) reviews under the FDA’s Accredited Persons Program.
RTS engineers, scientists, and clinicians have reviewed over 1,500 submissions in 18 years, averaging 10-14 days from receipt of submission to completion of initial review.
Recent Clearances - Updated as of July 30, 2022
GoodGloves Industries Sdn Bhd | Powder-Free Nitrile Examination Glove, Non-Sterile
polymer patient examination glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221877
NormaTec Industries, LP | Normatec Go
massager, powered inflatable tube
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221666
Inari Medical | Artix Ballon Guiding Sheath
catheter, percutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221846
Medi USA, L.P. | medi pneumatic compression system (pcs)-genius (Model 652)
sleeve, limb, compressible
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221654
Axial Medical Printing Limited | Axial3D Cloud Segmentation Service
system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221511
Siemens Medical Solutions USA, Inc | ACUSON Sequoia Diagnostic Ultrasound System
system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221500
3M Company ESPE Dental Products | 3M Filtek Supreme Flowable Restorative
material, tooth shade, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221695
Whill, Inc. | WHILL Model F
wheelchair, powered
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221438
Bard Peripheral Vascular, Inc | Liverty™ TIPS Access Set
introducer, catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221440
Siemens Medical Solutions USA, Inc. | syngo Dynamics (Version VA40E)
system, image processing, radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220832
SafeSource Direct, LLC | Procedure Mask with Ear Loops and Surgical Mask with Ties
mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221134
Acutus Medical, Inc. | AcQGuide® VUE Steerable Sheath
catheter, steerable
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221044
Strados Labs, Inc. | Strados Remote Electronic Stethoscope Platform (RESP)
Recorder, Magnetic Tape, Medical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220893
BB Imaging | TeleScan
System, Image Processing, Radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220767
ImaCor Inc | ImaCor Zura Handheld ZHH-010
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220490
KDI Med Supply | 3 Ply Medical Grade Single Use Procedural Disposable Face Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220637
Erchonia Corporation | Erchonia Zerona Z-Bed
Fat Reducing Low Level Laser
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220519
StratoScientific | Steth IO Spot
Stethoscope, Electronic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220196
K Line Europe GmbH | K Clear
Aligner, Sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220726
NormaTec Industries, LP | Normatec 3
Massager, Powered Inflatable Tube
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220217
Megine Industries Sdn Bhd | Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
Polymer Patient Examination Glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220232
GE Healthcare Information Technologies, Inc. | Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
Computer, Diagnostic, Programmable
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213972
Hong Qiangxing (Shen Zhen) Electronics Limited | TENS & PMS (Model: SM9126)
Stimulator, Nerve, Transcutaneous, Over-The-Counter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220150
Acutus Medical, Inc. | AcQCross Qx Integrated Transseptal Dilator/Needle
Introducer, Catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220047
OXOS Medical, Inc. | Micro C Medical Imaging System, M01
System, X-Ray, Mobile
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212654
Elastic Care Incorporated | LifePath Remote Patient Monitoring Platform
Transmitters And Receivers, Physiological Signal, Radiofrequency
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211822
3M Deutschland GmbH | Permadyne
Material, Impression
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220257
Traverse Vascular, Inc. | QuikPass Catheter
Catheter, Percutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K214106
Danameco Medical Joint Stock Corporation | D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213970
Xinxiang Kangbeier Medical Technology Co., Ltd. | Kangbeier Surgical Mask (Model: KBR-1001)
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213920
Stronghold Group LLC | Stronghold Group Nitrile Examination Glove, Powder Free
Polymer Patient Examination Glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213859
FUJIFILM Sonosite, Inc. | Sonosite PX Ultrasound System
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213763
Invivo Corporation | DS FootAnkle 16Ch Coils For 1.5T And 3.0T, DS HiRes HandWrist 16Ch Coils For 1.5T And 3.0T, Ds Small Extremity 16Ch Coils For 1.5T And 3.0T
Coil, Magnetic Resonance, Specialty
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213766
Cirdan Imaging Ltd | Solas OR
Cabinet, X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213691
Bedfont Scientific Ltd | ICOquit® Smokerlyzer®
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211918
UltiMed Incorporated | UltiCare Disposable Pen Needles
Needle, Hypodermic, Single Lumen
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213407
Texas MedPlast LLC | Savvy Mask - Level 3 Surgical Face Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213406
Whill, Inc. | WHILL Model C2
Wheelchair, Powered
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213383
Invivo Corporation (Business Trade Name: Philips) | Ds Head 32ch 3.0T
Coil, Magnetic Resonance, Specialty
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213351
Titan Manufacturing, Inc. | Titan Manufacturing Bipolar Forceps
Electrosurgical, Cutting & Coagulation & Accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213386
Philips Medizin Systeme Boeblingen GmbH | Philips IntelliVue GuardianSoftware (Rev. E.0X)
Display, Cathode-Ray Tube, Medical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212208
Zhuhai DR Medical Instruments Co., Ltd | DR Safety Syringe, Sterile Hypodermic Needle For Single Use
Syringe, Antistick
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212226
Philips Medical Systems | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212704
Biotech Dental Smilers, SAS | SMILERS
Aligner, Sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212961
ReMade USA LLC | Surgical Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212451
Diode Art Engineering Doing Business As Air Relax | Air Relax Pro Model AR-4.0
Massager, Powered Inflatable Tube
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212491
Pulmonx Corporation | Lung Image Analysis
System, X-Ray, Tomography, Computed
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212494
Deerfield Imaging, Inc. | IMRIS IMRI 3T V
System, Nuclear Magnetic Resonance Imaging
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212367
EchoNous, Inc. | Kosmos
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212100
Invivo Corporation | DynaCAD
System, Image Processing, Radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212175
Mid-America Safety Corp. | MASC Surgical Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211984
Athlos Oy | DC-Air And Athlos-1 And Athlos-Air
System, X-Ray, Extraoral Source, Digital
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211688
Siemens Medical Solutions USA, Inc | ACUSON Sequoia Diagnostic Ultrasound System
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211859
SpinTech, Inc. | STAGE
System, Nuclear Magnetic Resonance Imaging
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210843
JointVue LLC | 3d Echo V1.1
System, Image Processing, Radiological
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211656
Crystalline Medical | Vu-Path Ultrasound System
System, Imaging, Pulsed Doppler, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203657
Megine Industries Sdn Bhd | AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
Polymer Patient Examination Glove
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211310
PremiumEStore, LLC | Amerishield Surgical Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211520
OXOS Medical, Inc. | Micro C Medical Imaging System, M01
System, X-Ray, Mobile
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211473
American Surgical Mask Company LLC | ASM-301 Level 3 Surgical Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211440
Bistos Co., Ltd. | Infant Phototherapy Equipment
Unit, Neonatal Phototherapy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210289
MetriTrack, Inc. | Breast Volume Navigator (BVN) Model G-2000
System, Imaging, Pulsed Echo, Ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211098
Diode Art Engineering Doing Business As Air Relax | Air Relax Plus Model AR-3.0
Massager, Powered Inflatable Tube
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211460
PremiumEStore, LLC | AirMax Procedure Mask
Mask, Surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211275
CGX, LLC | Quick-20m
Amplifier, Physiological Signal
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203331
Acutus Medical, Inc. | Acqguide Max Steerable Sheath
Catheter, Steerable
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211100
Gilero, LLC | SmartSite Bag 500mL, SmartSite Bag 250 ML, SmartSite Bag 100 ML
Container, I.V.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201936
Scientia Vascular LLC | Plato 17 Microcatheter
Catheter, Percutaneous
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210601
3M Company | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
Aligner, Sequential
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211190
Introducer, Catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210685
Imaging, Pulsed Doppler, Ultrasonic System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210743
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202708
Caries Detection Device
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200601
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210487
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210225
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210063
Stimulator, Muscle, Powered, For Muscle Conditioning
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210174
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203425
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202214
Percutaneous Catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203275
Surgical Mask
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203265
Cardiovascular Surgical Vascular Clamp
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203803
Orthopedic Diagnostic Arthroscope
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203526
Mobile X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203658
Powered Inflatable Tube Massager, Physical Medicine Therapy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203552
PACS
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203249
Image-intensified Fluoroscopic X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203087
Computed Tomography X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203216
PACS
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203058
Intravascular Administration Set, General Hospital and Personal Use Therapy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200425
Vaginal Stent, Obstetrical and Gynecological Prosthetic Device
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202542
Stationary X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202564
Gastroenterology Urology Catheter and Accessories
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202566
Orthodontic Plastic Bracket, Dental Therapy
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202685
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202406
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202216
Self-Retaining Retractor For Neurosurgery
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202072
Biopsy Instrument, Gastroenterology Urology
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202012
Orthodontic Plastic Bracket
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193130
Percutaneous Cardiovascular Catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201076
Stethoscope, Cardiovascular Diagnostic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201299
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201633
Dental Prosthetic Tooth Shade Resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201668
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201130
Computed Tomography X-Ray System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201053
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200964
Neurovascular Percutaneous Catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200910
Magnetic Resonance Diagnostic Device
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200327
Anesthesia conduction catheter, percutaneous introducer
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200624
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200707
Prefilled Syringe
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200556
Cardiovascular Monitoring Blood Flowmeter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200337
Drug Dose Calculator
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200443
Ultrasonic Pulsed Doppler Imaging System
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200304
Orthodontic Plastic Bracket
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200214
Orthodontic Plastic Bracket
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200148
General and Plastic Surgery Laparoscope
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200228
PACS
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200179
The list is not all-inclusive. All devices reviewed by RTS are listed on the FDA website.