MP3000 Series III Video Imager

FDA 510(k) K921992 · International Imaging Electronics

Substantially Equivalent

510(k) numberK921992

Submission

Device name
MP3000 Series III Video Imager
Applicant
International Imaging Electronics
Addison, IL, US
Received
April 22, 1992
Decision date
July 10, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 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 MP3000 Series III Video Imager cleared by the FDA?

MP3000 Series III Video Imager (K921992) received a 510(k) decision of Substantially Equivalent on July 10, 1992, 79 days after the submission was received.

What is the product code of K921992?

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