Cleared Traditional

K943652 - VASCULAR MP X-RAY GENERATOR

K943652 is an FDA 510(k) clearance for VASCULAR MP X-RAY GENERATOR, manufactured by GE Medical Systems. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 25-day FDA review.

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

FDA 510(k) Submission Details - K943652

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.

IZO Device Classification - Class 1, General Controls

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 96
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K943652.
MICRO X-30HF
K944148 · Fischer Imaging Corp. · Sep 1994
MICRO X-80 HF
K944149 · Fischer Imaging Corp. · Sep 1994
MICRO X-65 HF
K944150 · Fischer Imaging Corp. · Sep 1994
RSX-525HF
K943504 · Fischer Imaging Corp. · Aug 1994
MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
K942778 · Varian Assoc., Inc. · Jul 1994
MODEL TM EP HIGH VOLTAGE GENERATOR
K942100 · Continental X-Ray Corp. · Jun 1994