Cleared Traditional

K913798 - SONOLAYER ALPHA, MODEL SSH-140A

K913798 is an FDA 510(k) clearance for SONOLAYER ALPHA, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K913798 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
219d
Days
Class 2
Risk

K913798 is an FDA 510(k) clearance for the SONOLAYER ALPHA, MODEL SSH-140A. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on April 1, 1992 after a review of 219 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Toshiba America Medical Systems, In.C devices

FDA 510(k) Submission Details - K913798

510(k) Number K913798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1991
Decision Date April 01, 1992
Days to Decision 219 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
112d slower than avg
Panel avg: 107d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 329
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K913798.
SACA, 3.5 MHZ PROBE
K905200 · Diasonics, Inc. · Apr 1992
BIPLANE TRANSRECTAL PROBE
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ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER
K920678 · Interspec, Inc. · Apr 1992
LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM
K913472 · Baxter Healthcare Corp · Mar 1992
CW DOPPLER 2.25 MHZ PROBE
K903562 · Diasonics, Inc. · Mar 1992
PSG(TM) 20 GUAGE DOPPLER NEEDLE
K913941 · Peripheral Systems Group · Feb 1992