Clearance Summary
VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM received FDA 510(k) clearance under submission number K952672, sponsored by Bennett X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-07-13.
- Submission: K952672
- Applicant / Sponsor: Bennett X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 1995-07-13
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.