Clearance Summary
3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT received FDA 510(k) clearance under submission number K912225, sponsored by 3M Medical Products Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1991-07-22.
- Submission: K912225
- Applicant / Sponsor: 3M Medical Products Group
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1991-07-22
Classification & Regulation
This clearance is catalogued under FDA product code IXW and 21 CFR 892.1900, within the Radiology review panel as a Class II device.