Clearance Summary
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 received FDA 510(k) clearance under submission number K091195, sponsored by Philips Medical Systems (Cleveland), Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-05-27.
- Submission: K091195
- Applicant / Sponsor: Philips Medical Systems (Cleveland), Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2009-05-27
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.