Cleared Traditional

K893996 - CUSIS ULTRASOUND SKIN IMAGING SYSTEM

K893996 is an FDA 510(k) clearance for CUSIS ULTRASOUND SKIN IMAGING SYSTEM, manufactured by Stiefel Research Institute, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K893996 · Stiefel Research Institute, Inc. · Radiology device
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Sep 1989
Decision
108d
Days
Class 2
Risk

K893996 is an FDA 510(k) clearance for the CUSIS ULTRASOUND SKIN IMAGING SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Stiefel Research Institute, Inc. (Oakhill, US). The FDA issued a Cleared decision on September 21, 1989 after a review of 108 days - within the typical 510(k) review window.

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 Stiefel Research Institute, Inc. devices

FDA 510(k) Submission Details - K893996

510(k) Number K893996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1989
Decision Date September 21, 1989
Days to Decision 108 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 107d · This submission: 108d
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 692
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K893996.
IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC
K896150 · Teknar, Inc. · Jan 1990
CIVCO LATEX ULTRASOUND SHEATHS
K895614 · CIVCO Medical Instruments Co., Inc. · Dec 1989
SIEMENS ENDO-P-PROBE
K894806 · Siemens Medical Solutions USA, Inc. · Oct 1989
DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A
K892386 · Toshiba America Medical Systems, In.C · Sep 1989
SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT
K890913 · Shimadzu Precision Instruments, Inc. · Sep 1989
CVIS ULTRA-SCAN ONE IMAGING CATHETER
K893837 · Cardiovascular Imaging Systems, Inc. · Aug 1989