Ultra Compact Video Imager

FDA 510(k) K930755 · International Imaging Electronics

Substantially Equivalent

510(k) numberK930755

Submission

Device name
Ultra Compact Video Imager
Applicant
International Imaging Electronics
Bolingbrook, IL, US
Received
February 12, 1993
Decision date
September 28, 1993
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 Ultra Compact Video Imager cleared by the FDA?

Ultra Compact Video Imager (K930755) received a 510(k) decision of Substantially Equivalent on September 28, 1993, 228 days after the submission was received.

What is the product code of K930755?

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