Cleared Traditional

U-MAT (K790466) - FDA 510(k) Clearance

Class I Radiology device.

K790466 · Engineering Dynamics Corp. · Radiology device
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Mar 1979
Decision
23d
Days
Class 1
Risk

K790466 is an FDA 510(k) clearance for the U-MAT. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Engineering Dynamics Corp. (Mchenry, US). The FDA issued a Cleared decision on March 28, 1979 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Engineering Dynamics Corp. devices

Submission Details

510(k) Number K790466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1979
Decision Date March 28, 1979
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 29
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K790466.
MAXI CAMERA 37
K801653 · General Electric Co. · Aug 1980
MAXI CAMERA 61
K801654 · General Electric Co. · Aug 1980
A2 IMAGE PROCESSING SYSTEM
K801368 · Medtronic Vascular · Jul 1980
MODU-SET COLLIMOTOR
K790463 · Medtronic Vascular · Mar 1979
MAXI CAMERA 400T
K782029 · General Electric Co. · Dec 1978
PROCESSING SYSTEM, A2 IMAGE
K782047 · Medtronic Vascular · Dec 1978