Cleared Traditional

VASCULAR MP X-RAY GENERATOR (K943652) - FDA 510(k) Clearance

Class I Radiology device.

K943652 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
25d
Days
Class 1
Risk

K943652 is an FDA 510(k) clearance for the VASCULAR MP X-RAY GENERATOR. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on August 22, 1994 after a review of 25 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 GE Medical Systems devices

Submission Details

510(k) Number K943652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1994
Decision Date August 22, 1994
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
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 29
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K943652.
MPH50, MPH65, AND MPH80
K954666 · GE Medical Systems · Nov 1995
POLYDOROS SX 65 AND 80
K950883 · Siemens Medical Solutions USA, Inc. · Apr 1995
KXO-80G
K945668 · Toshiba America Medical Systems, In.C · Dec 1994
SCPU X-RAY GENERATOR
K940227 · General Electric Co. · Apr 1994
POYDOROS LX
K931930 · Siemens Medical Solutions USA, Inc. · Sep 1993
POLYDOROS IS
K933240 · Siemens Medical Solutions USA, Inc. · Sep 1993