Cleared Traditional

DATA CAMERA (K780491) - FDA 510(k) Clearance

Class I Radiology device.

K780491 · General Electric Co. · Radiology device
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Apr 1978
Decision
22d
Days
Class 1
Risk

K780491 is an FDA 510(k) clearance for the DATA CAMERA. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1978 after a review of 22 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 General Electric Co. devices

Submission Details

510(k) Number K780491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1978
Decision Date April 18, 1978
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
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 24
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K780491.
MAXI CAMERA 400T
K782029 · General Electric Co. · Dec 1978
PROCESSING SYSTEM, A2 IMAGE
K782047 · Medtronic Vascular · Dec 1978
MAXI-CAMERA 535
K781673 · General Electric Co. · Oct 1978
PORTA CAMERA IIC
K770753 · General Electric Co. · May 1977
MAXICAMERA II
K770343 · General Electric Co. · Feb 1977
PORTACAMERA 11-B
K761159 · General Electric Co. · Dec 1976