Clearance Summary
PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM received FDA 510(k) clearance under submission number K964485, sponsored by Eliav , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-02-04.
- Submission: K964485
- Applicant / Sponsor: Eliav , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1997-02-04
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.