Clearance Summary
SONOS IMAGING SYSTEM (2000/2500 & 1000/1500) received FDA 510(k) clearance under submission number K952540, sponsored by Hewlett-Packard Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-03-11.
- Submission: K952540
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1996-03-11
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.