Cleared Traditional

K884930 - COMPAX MODEL 40

K884930 is the FDA 510(k) clearance for COMPAX MODEL 40 by General Electric Co.. It is a Class 2 Radiology device (product code IZZ) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K884930 · General Electric Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
27d
Days
Class 2
Risk

K884930 is an FDA 510(k) clearance for the COMPAX MODEL 40, 400, 400T. Classified as Table, Radiographic, Non-tilting, Powered (product code IZZ), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 K884930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1988
Decision Date December 22, 1988
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZZ Table, Radiographic, Non-tilting, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IZZ Table, Radiographic, Non-tilting, Powered

All 12
Devices cleared under the same product code (IZZ) and FDA review panel - the closest regulatory comparables to K884930.
CATHERIZATION KS-50
K920732 · Shimadzu Medical Systems · Apr 1992
CAT-250B
K915413 · Toshiba America Medical Systems, In.C · Dec 1991
EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
K893452 · Warner-Lambert Co. · Jun 1989
TANGENT II
K883974 · Fischer Imaging Corp. · Oct 1988
VRT TABLE
K827928 · General Electric Co. · Sep 1982
RX PEDESTAL TABLE
K772283 · General Electric Co. · Dec 1977