Cleared Traditional

K910902 - VMX MOBILE X-RAY SYSTEM

K910902 is an FDA 510(k) clearance for VMX MOBILE X-RAY SYSTEM, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K910902 · GE Medical Systems · Radiology device
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Sep 1991
Decision
188d
Days
Class 2
Risk

K910902 is an FDA 510(k) clearance for the VMX MOBILE X-RAY SYSTEM. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on September 9, 1991 after a review of 188 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 GE Medical Systems devices

FDA 510(k) Submission Details - K910902

510(k) Number K910902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1991
Decision Date September 09, 1991
Days to Decision 188 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 107d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 132
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K910902.
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
K001517 · Shimadzu Corp. · Jun 2000
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K932106 · Siemens Medical Solutions USA, Inc. · Sep 1994
MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM
K893637 · Shimadzu Medical Systems · Jul 1989
BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR
K883092 · Bennett X-Ray Corp. · Oct 1988
BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A
K874840 · Bennett X-Ray Corp. · Jan 1988