Cleared Traditional

AMX-III (K802047) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 92
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K802047.
MOBILETT PLUS MOBILE X-RAY SYSTEM
K932106 · Siemens Medical Solutions USA, Inc. · Sep 1994
MX MOBILE X-RAY SYSTEM
K862452 · Philips Medical Systems (Cleveland), Inc. · Jul 1986
APR MOBILE
K843192 · Philips Medical Systems (Cleveland), Inc. · Sep 1984
CAP-MOBILE
K781425 · Philips Medical Systems (Cleveland), Inc. · Sep 1978
HITACHI TECH-MOBLE DHC-121
K780313 · Philips Medical Systems (Cleveland), Inc. · Mar 1978
MOBILE X-RAY SYS. MODEL 43820A
K771571 · Hewlett-Packard Co. · Aug 1977