Cleared Traditional

KXO-80C/80D (K904043) - FDA 510(k) Clearance

Class I Radiology device.

K904043 · Toshiba America Medical Systems, In.C · Radiology device
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Nov 1990
Decision
86d
Days
Class 1
Risk

K904043 is an FDA 510(k) clearance for the KXO-80C/80D. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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 Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K904043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1990
Decision Date November 29, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
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 - IZO Generator, High-voltage, X-ray, Diagnostic

All 22
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K904043.
POLYDOROS C
K924078 · Siemens Medical Solutions USA, Inc. · Jan 1993
POLYDOROS XS50 AND SX80
K923786 · Siemens Medical Solutions USA, Inc. · Dec 1992
MPG 65-80-100 X-RAY GENERATOR AND CONTROL
K921951 · General Electric Co. · Jul 1992
SMX GENERATOR
K862800 · General Electric Co. · Aug 1986
MVP GENERATOR, CATALOG NO. H8018
K862682 · General Electric Co. · Jul 1986
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823 · Philips Medical Systems (Cleveland), Inc. · Apr 1985