Clearance Summary
DIRECT DIGITIZER REGIUS MODEL 370 received FDA 510(k) clearance under submission number K051418, sponsored by Konica Minolta Medical & Graphic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-07-01.
- Submission: K051418
- Applicant / Sponsor: Konica Minolta Medical & Graphic, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2005-07-01
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.