Cleared Traditional

CT MAX 640 #B7940 JA/JE (K882581) - FDA 510(k) Clearance

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

K882581 · General Electric Co. · Radiology device
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Aug 1988
Decision
54d
Days
Class 2
Risk

K882581 is an FDA 510(k) clearance for the CT MAX 640 #B7940 JA/JE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on August 15, 1988 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 K882581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1988
Decision Date August 15, 1988
Days to Decision 54 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
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 351
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K882581.
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K903763 · General Electric Co. · Nov 1990
CT SYTEC 3000
K893820 · General Electric Co. · Aug 1989
P-7 COMPUTED TOMOGRAPHY SYSTEM
K882378 · Philips Medical Systems (Cleveland), Inc. · Oct 1988
XENON CT
K875088 · Siemens Medical Solutions USA, Inc. · Jul 1988
SOMATOM PLUS
K880965 · Siemens Medical Solutions USA, Inc. · Mar 1988
CT PACE CATALOG NUMBER B7950A
K872526 · General Electric Co. · Sep 1987