Regulatory Technology Services (RTS) is the #1 FDA Accredited Third Party 510k Review Organization to perform 510(k) reviews under the FDA’s Accredited Persons Program (3P510k)

RTS' purpose is to perform third-party review of 510(k) submissions.

Regulatory Technology Services (RTS) is registered with the state of Minnesota.

RTS has reviewed the following types of devices:

Cardiovascular Catheters   |   Dental Aligners, Resins, Amalgams   |   EEG   |   Electro Surgical Lasers   |  
Laparoscopes   |   MRI and Coils   |   Neurovascular Devices   |   NIBP, ECG Monitors, Stethoscopes   |  
SAMD   |   Physical Medicine Therapy   |   Picture Archiving Systems (PACS)   |   Ultrasound   |   X-Ray and CT

The list is not all-inclusive. Devices that RTS is qualified to review are listed on FDA website.