Cleared Traditional

5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER (K894054) - FDA 510(k) Clearance

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

K894054 · Advanced Technology Laboratories, Inc. · Radiology device
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Sep 1989
Decision
97d
Days
Class 2
Risk

K894054 is an FDA 510(k) clearance for the 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER. 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 Advanced Technology Laboratories, Inc. (Bothell, US). The FDA issued a Cleared decision on September 12, 1989 after a review of 97 days - within the typical 510(k) review window.

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. 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 Advanced Technology Laboratories, Inc. devices

Submission Details

510(k) Number K894054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1989
Decision Date September 12, 1989
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
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 609
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K894054.
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K933202 · GE Medical Systems · Jun 1994
PULSED DOPPLER OPTION, CONTINU-WAVE
K842407 · General Electric Co. · Feb 1985
PICKER ARTIS ULTRASOUND IMAGING SYS
K842055 · Philips Medical Systems (Cleveland), Inc. · Aug 1984
DOPPLER IMAGING OPTION
K840140 · Hewlett-Packard Co. · Aug 1984