Clearance Summary
DRY LASER IMAGER, DRYPRO MODEL 832 received FDA 510(k) clearance under submission number K061999, 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 2006-08-15.
- Submission: K061999
- Applicant / Sponsor: Konica Minolta Medical & Graphic, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2040
- Decision date: 2006-08-15
Classification & Regulation
This clearance is catalogued under FDA product code LMC and 21 CFR 892.2040, within the Radiology review panel as a Class II device.