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 October 22, 2021


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.

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