Clearance Summary
BCM-ARC 105 X-RAY MOBILE UNIT received FDA 510(k) clearance under submission number K890306, sponsored by B C Medical , 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 1989-04-17.
- Submission: K890306
- Applicant / Sponsor: B C Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 1989-04-17
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.