Regulatory Technology Services

Regulatory Technology Services (RTS) is the #1 FDA Accredited Third Party 510k Review Organization (3PRO to perform 510(k) reviews under the FDA’s Accredited Persons Program (3P510k). Since our inception, RTS engineers, scientists, and clinicians have reviewed over 1,500 submissions averaging 10-14 days from receipt of submission to completion of substantive review. Recent Clearances - Updated as of November 5, 2022 Philips Ultrasound LLC | Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) system, imaging, pulsed doppler, ultrasonic DETAX GmbH | FREEPRINT crown material, tooth shade, resin Lamidey Noury Medical | MCB UNIT Model: V10GMCBUS unit, electrosurgical, endoscopic (with or without accessories) LightForce Orthodontics | LightForce Orthodontic System bracket, ceramic, orthodontic Shanghai Kindly Medical Instruments Co, Ltd | INT Introducer Set introducer, catheter Qingdao Yasee Medical Device Co, Ltd.| Infrared Forehead Thermometer thermometer, electronic, clinical Phu Bao Group Company Limited | Perfetta Moderate Medical Face Mask mask, surgical Invivo Corporation (Business Trade Name: Philips)| 8ch Wrist Coil coil, magnetic resonance, specialty