510(k) K042133

DRY LASER IMAGER, MODEL DRYPRO MODEL 793 by Konica Minolta Medical & Graphic, Inc. — Product Code LMC

K042133 is an FDA 510(k) premarket notification submitted by Konica Minolta Medical & Graphic, Inc. for the device "DRY LASER IMAGER, MODEL DRYPRO MODEL 793". The FDA issued a decision of Substantially Equivalent on November 24, 2004. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Konica Minolta Medical & Graphic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2004
Date Received
August 9, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type