Clearance Summary
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 received FDA 510(k) clearance under submission number K032681, sponsored by Konica Medical and Graphic Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-09-24.
- Submission: K032681
- Applicant / Sponsor: Konica Medical and Graphic Corporation
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2040
- Decision date: 2003-09-24
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.