Cleared Traditional

K802047 - AMX-III

K802047 is an FDA 510(k) clearance for AMX-III, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K802047 · General Electric Co. · Radiology device
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Oct 1980
Decision
59d
Days
Class 2
Risk

K802047 is an FDA 510(k) clearance for the AMX-III. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 59 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 General Electric Co. devices

FDA 510(k) Submission Details - K802047

510(k) Number K802047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1980
Decision Date October 23, 1980
Days to Decision 59 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
48d faster than avg
Panel avg: 107d · This submission: 59d
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 176
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K802047.
APR MOBILE
K843192 · Philips Medical Systems (Cleveland), Inc. · Sep 1984
PMX MOBILE X-RAY SYSTEM
K833226 · Philips Medical Systems, Inc. · Oct 1983
TECHNY REX 3000 MOBILE X-RAY UNIT
K803103 · Tecnomed, Inc. · Jan 1981
MOBIL XR
K781705 · Siemens Corp. · Oct 1978
CAP-MOBILE
K781425 · Philips Medical Systems (Cleveland), Inc. · Sep 1978
X-RAY, PORTABLE
K781276 · Air-Shields, Inc. · Aug 1978