Clearance Summary
1989 SOFTWARE REVISION TO THE BMT-1100 received FDA 510(k) clearance under submission number K894714, sponsored by Bruker Medical Imaging, 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 1989-11-15.
- Submission: K894714
- Applicant / Sponsor: Bruker Medical Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 1989-11-15
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.