Clearance Summary
VISUALIZER 2000 received FDA 510(k) clearance under submission number K943272, sponsored by Vf-Works, 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 1994-12-27.
- Submission: K943272
- Applicant / Sponsor: Vf-Works, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1994-12-27
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.