Cleared Traditional

K940332 - MODEL FORTY ULTRA COMPACT VIDEO IMAGER

K940332 is an FDA 510(k) clearance for MODEL FORTY ULTRA COMPACT VIDEO IMAGER, manufactured by International Imaging Electronics. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 135-day FDA review.

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

FDA 510(k) Submission Details - K940332

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
Combination Product No
PCCP Authorized No
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.

LMC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LMC Camera, Multi Format, Radiological

All 45
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K940332.
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
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ULTRA COMPACT VIDEO IMAGER
K930755 · International Imaging Electronics · Sep 1993
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K925220 · Heraeus Kulzer, Inc. · May 1993
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K923481 · Philips Medical Systems, Inc. · May 1993