Cleared Traditional

SCPU X-RAY GENERATOR (K940227) - FDA 510(k) Clearance

Class I Radiology device.

K940227 · General Electric Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
100d
Days
Class 1
Risk

K940227 is an FDA 510(k) clearance for the SCPU X-RAY GENERATOR. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all General Electric Co. devices

Submission Details

510(k) Number K940227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1994
Decision Date April 28, 1994
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 107d · This submission: 100d
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 21
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K940227.
POLYDOROS SX 65 AND 80
K950883 · Siemens Medical Solutions USA, Inc. · Apr 1995
POYDOROS LX
K931930 · Siemens Medical Solutions USA, Inc. · Sep 1993
POLYDOROS IS
K933240 · Siemens Medical Solutions USA, Inc. · Sep 1993
LCR GENERATOR
K931998 · Philips Medical Systems (Cleveland), Inc. · Jul 1993
POLYDOROS C
K924078 · Siemens Medical Solutions USA, Inc. · Jan 1993
POLYDOROS XS50 AND SX80
K923786 · Siemens Medical Solutions USA, Inc. · Dec 1992