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510(k) K032681

KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 by Konica Medical and Graphic Corporation — Product Code LMC

K032681 is an FDA 510(k) premarket notification submitted by Konica Medical and Graphic Corporation for the device "KONICA LASER IMAGER, MODEL DRYPRO MODEL 771". The FDA issued a decision of Substantially Equivalent on September 24, 2003. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2003
Date Received
August 29, 2003
Clearance Type
Special
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

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  • K072680 — DRYSTAR AXYS, MODEL EYZ4E (October 25, 2007)
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FDA data resources