Clearance Summary
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) received FDA 510(k) clearance under submission number K222648, sponsored by Philips Ultrasound, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-09-27.
- Submission: K222648
- Applicant / Sponsor: Philips Ultrasound, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2022-09-27
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.