Cleared Traditional

K873982 - GX-MOBILE X-RAY UNIT

K873982 is an FDA 510(k) clearance for GX-MOBILE X-RAY UNIT, manufactured by Gendex Corp.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K873982 · Gendex Corp. · Radiology device
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Oct 1987
Decision
30d
Days
Class 2
Risk

K873982 is an FDA 510(k) clearance for the GX-MOBILE X-RAY UNIT. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Gendex Corp. (Franklin Park, US). The FDA issued a Cleared decision on October 30, 1987 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gendex Corp. devices

FDA 510(k) Submission Details - K873982

510(k) Number K873982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1987
Decision Date October 30, 1987
Days to Decision 30 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
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 182
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K873982.
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
MX MOBILE X-RAY SYSTEM
K862452 · Philips Medical Systems (Cleveland), Inc. · Jul 1986
MODEL MBA-130 MOBILE X-RAY SYSTEM
K862118 · Elscint, Inc. · Jun 1986
APR MOBILE
K843192 · Philips Medical Systems (Cleveland), Inc. · Sep 1984