REGULATORY TECHNOLOGY SERVICES Information

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 https://www.rts3pro.com/index.html Philips Ultrasound LLC | 5000 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 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222648 DETAX GmbH | FREEPRINT crown material, tooth shade, resin https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222877 Lamidey Noury Medical | MCB UNIT Model: V10GMCBUS unit, electrosurgical, endoscopic (with or without accessories) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222542 LightForce Orthodontics | LightForce Orthodontic System bracket, ceramic, orthodontic https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222764 Shanghai Kindly Medical Instruments Co., Ltd | INT Introducer Set introducer, catheter https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222647 Qingdao Yasee Medical Device Co., Ltd. | Infrared Forehead Thermometer thermometer, electronic, clinical https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220084 Phu Bao Group Company Limited | Perfetta Moderate Medical Face Mask mask, surgical https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222426 Invivo Corporation (Business Trade Name: Philips) | 8ch Wrist Coil coil, magnetic resonance, specialty https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222325