Cleared Traditional

MAXI CAMERA 37 (K801653) - FDA 510(k) Clearance

Class I Radiology device.

K801653 · General Electric Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1980
Decision
33d
Days
Class 1
Risk

K801653 is an FDA 510(k) clearance for the MAXI CAMERA 37. 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 August 20, 1980 after a review of 33 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 K801653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1980
Decision Date August 20, 1980
Days to Decision 33 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
74d faster than avg
Panel avg: 107d · This submission: 33d
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 K801653.
MAXI CAMERA/D
K811676 · General Electric Co. · Jul 1981
MEDTRONIC A2 CLINICAL IMAGING SYSTEM
K811187 · Medtronic Vascular · May 1981
A2 IMAGE PROCESSING SYSTEM
K802475 · Medtronic Vascular · Nov 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