Cleared Traditional

K896173 - ULTRASCAN(R)

K896173 is an FDA 510(k) clearance for ULTRASCAN, manufactured by Topical Delivery Systems. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K896173 · Topical Delivery Systems · Radiology device
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Apr 1990
Decision
168d
Days
Class 2
Risk

K896173 is an FDA 510(k) clearance for the ULTRASCAN(R). Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Topical Delivery Systems (Hartland, US). The FDA issued a Cleared decision on April 11, 1990 after a review of 168 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Topical Delivery Systems devices

FDA 510(k) Submission Details - K896173

510(k) Number K896173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1989
Decision Date April 11, 1990
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 703
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K896173.
AUSONICS 5000
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ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K896755 · Ge Medical Systems Information Technologies · May 1990
ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U322
K884644 · Hitachi Medical Corp. of America · Apr 1990
BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM
K895645 · Biosound, Inc. · Mar 1990
IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC
K896150 · Teknar, Inc. · Jan 1990
CIVCO LATEX ULTRASOUND SHEATHS
K895614 · CIVCO Medical Instruments Co., Inc. · Dec 1989