3M 1154 Laser Imager

FDA 510(k) K936142 · 3M Information,Imaging and Electronic Sector

Substantially Equivalent

510(k) numberK936142

Submission

Device name
3M 1154 Laser Imager
Applicant
3M Information,Imaging and Electronic Sector
St. Paul, MN, US
Received
December 27, 1993
Decision date
September 16, 1994
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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More from Mitsubishi Electric Corporation Kyoto Works

510(k)DeviceDecision
K9361523M 1152 Laser ImagerLMC · Traditional 09/21/1994SE
K9361533M 1156 Multi-Input SystemLMD · Traditional 05/23/1994SE

Questions and answers

When was 3M 1154 Laser Imager cleared by the FDA?

3M 1154 Laser Imager (K936142) received a 510(k) decision of Substantially Equivalent on September 16, 1994, 263 days after the submission was received.

What is the product code of K936142?

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