Cleared Traditional

VENUS DIAGNOSTIC ULTRASOUND SYSTEM (K933202) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933202 · GE Medical Systems · Radiology device
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Jun 1994
Decision
361d
Days
Class 2
Risk

K933202 is an FDA 510(k) clearance for the VENUS DIAGNOSTIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on June 27, 1994 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K933202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1993
Decision Date June 27, 1994
Days to Decision 361 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
254d slower than avg
Panel avg: 107d · This submission: 361d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 632
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K933202.
PHILIPS ULTRASOUND P800 IMAGING SYSTEM
K935923 · Hewlett-Packard Co. · Dec 1994
SSA-380A
K933743 · Toshiba America Medical Systems, In.C · Oct 1994
HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION
K934041 · Hewlett-Packard Co. · Sep 1994
SSH-140A FETAL DOPPLER SYSTEM
K931293 · Toshiba America Medical Systems, In.C · Feb 1994
DOPPLER OPTION FOR PLATINUM
K902691 · Philips Medical Systems, Inc. · Jan 1991
PULSED DOPPLER OPTION, CONTINU-WAVE
K842407 · General Electric Co. · Feb 1985