Clearance Summary
OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) received FDA 510(k) clearance under submission number K951806, sponsored by Opgal Optronic Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1995-07-06.
- Submission: K951806
- Applicant / Sponsor: Opgal Optronic Industries
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 1995-07-06
Classification & Regulation
This clearance is catalogued under FDA product code LHQ and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class I device.