3M Color Laser Imager, Model 979

FDA 510(k) K923222 · 3M Medical Products Group

Substantially Equivalent

510(k) numberK923222

Submission

Device name
3M Color Laser Imager, Model 979
Applicant
3M Medical Products Group
St Paul, MN, US
Received
July 1, 1992
Decision date
September 30, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 3M Color Laser Imager, Model 979 cleared by the FDA?

3M Color Laser Imager, Model 979 (K923222) received a 510(k) decision of Substantially Equivalent on September 30, 1992, 91 days after the submission was received.

What is the product code of K923222?

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