Cleared Traditional

K940332 - MODEL FORTY ULTRA COMPACT VIDEO IMAGER (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K940332 · International Imaging Electronics · Radiology device
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Jun 1994
Decision
135d
Days
Class 2
Risk

K940332 is an FDA 510(k) clearance for the MODEL FORTY ULTRA COMPACT VIDEO IMAGER. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by International Imaging Electronics (Bolingbrook, US). The FDA issued a Cleared decision on June 8, 1994 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all International Imaging Electronics devices

Submission Details

510(k) Number K940332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1994
Decision Date June 08, 1994
Days to Decision 135 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 107d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.