Cleared Traditional

K913798 - SONOLAYER ALPHA

K913798 is the FDA 510(k) clearance for SONOLAYER ALPHA by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (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
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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

Submission Details

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.

Device Classification

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 188
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K913798.
SONOS 100 ULTRASOUND IMAGING SYSTEM
K921036 · Hewlett-Packard Co. · May 1992
SACA, 3.5 MHZ PROBE
K905200 · Diasonics, Inc. · Apr 1992
BIPLANE TRANSRECTAL PROBE
K914006 · Biosound, 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
PSF-50ET
K910850 · Toshiba America Medical Systems, In.C · Jan 1992