Clearance Summary
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 received FDA 510(k) clearance under submission number K052095, sponsored by Konica Minolta Medical & Graphic, 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 2005-11-03.
- Submission: K052095
- Applicant / Sponsor: Konica Minolta Medical & Graphic, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2005-11-03
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.