Cleared Traditional

K892943 - MULTI PULSE POWER UNIT GENERATOR

K892943 is an FDA 510(k) clearance for MULTI PULSE POWER UNIT 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 31-day FDA review.

K892943 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
31d
Days
Class 1
Risk

K892943 is an FDA 510(k) clearance for the MULTI PULSE POWER UNIT GENERATOR. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on May 22, 1989 after a review of 31 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 - K892943

510(k) Number K892943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1989
Decision Date May 22, 1989
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
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 K892943.
VPW 2877D5, X-RAY POWER SUPPLY
K902106 · Varian Assoc., Inc. · Aug 1990
30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE
K894479 · Bennett X-Ray Corp. · Sep 1989
RME 325R
K893674 · Fischer Imaging Corp. · Jul 1989
ESP 3-PHASE X-RAY GENERATORS
K884678 · Elscint, Inc. · Jan 1989
CFX 625
K883976 · Fischer Imaging Corp. · Dec 1988
MICRO-X 100CP
K884134 · Fischer Imaging Corp. · Oct 1988