Cleared Traditional

K953165 - ULTRA COMPACT VIDEO IMAGER

K953165 is an FDA 510(k) clearance for 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 305-day FDA review.

K953165 · International Imaging Electronics · Radiology device
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May 1996
Decision
305d
Days
Class 2
Risk

K953165 is an FDA 510(k) clearance for the 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 May 7, 1996 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K953165

510(k) Number K953165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1995
Decision Date May 07, 1996
Days to Decision 305 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
198d slower than avg
Panel avg: 107d · This submission: 305d
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 90
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K953165.
CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)
K962364 · Codonics, Inc. · Nov 1996
FUJI MEDICAL DRY IMAGER FM-DP 2636
K962967 · Fujifilm Medical System U.S.A., Inc. · Oct 1996
ASPECT OPTICAM
K962051 · Aspect Electronics, Inc. · Aug 1996
SIENET TELERADIOLOGY PRODUCT LINE
K955394 · Siemens Medical Solutions USA, Inc. · Feb 1996
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
K950721 · Fujifilm Medical System U.S.A., Inc. · May 1995
FIKO FO
K950610 · Fujifilm Medical System U.S.A., Inc. · Apr 1995