Clearance Summary
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM received FDA 510(k) clearance under submission number K043333, sponsored by Vital Images, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-12-15.
- Submission: K043333
- Applicant / Sponsor: Vital Images, Inc.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2004-12-15
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.