Clearance Summary
DRY LASER IMAGER, MODEL DRYPRO MODEL 793 received FDA 510(k) clearance under submission number K042133, 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 2004-11-24.
- Submission: K042133
- 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: 2004-11-24
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.