Clearance Summary
RSVP HALF SPHERE PHANTOM, MODEL DDP010 received FDA 510(k) clearance under submission number K082909, sponsored by The Phantom Laboratory, 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 2008-12-23.
- Submission: K082909
- Applicant / Sponsor: The Phantom Laboratory, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2008-12-23
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.