Clearance Summary
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM received FDA 510(k) clearance under submission number K010772, sponsored by Imaging Services, 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 2001-08-23.
- Submission: K010772
- Applicant / Sponsor: Imaging Services, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2001-08-23
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.