Konica Laser Imager, Model Drypro Model 771

FDA 510(k) K032681 · Konica Medical and Graphic Corporation

Substantially Equivalent

510(k) numberK032681

Submission

Device name
Konica Laser Imager, Model Drypro Model 771
Applicant
Konica Medical and Graphic Corporation
Mie-Ken, JP
Received
August 29, 2003
Decision date
September 24, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LMC – Camera, Multi Format, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2040
Specialty
Radiology

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Questions and answers

When was Konica Laser Imager, Model Drypro Model 771 cleared by the FDA?

Konica Laser Imager, Model Drypro Model 771 (K032681) received a 510(k) decision of Substantially Equivalent on September 24, 2003, 26 days after the submission was received.

What is the product code of K032681?

The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.