Clearance Summary
DS CASSETTE received FDA 510(k) clearance under submission number K053173, 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 2005-12-15.
- Submission: K053173
- Applicant / Sponsor: Konica Minolta Medical & Graphic, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1850
- Decision date: 2005-12-15
Classification & Regulation
This clearance is catalogued under FDA product code IXA and 21 CFR 892.1850, within the Radiology review panel as a Class II device.