510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K913798Substantially Equivalent

Sonolayer Alpha, Model Ssh-140A

Toshiba America Medical Systems, In.C, Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913798 is the FDA 510(k) clearance record for SONOLAYER ALPHA, MODEL SSH-140A, a class II device, cleared for Toshiba America Medical Systems, In.C on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list 146 510(k) clearances for Toshiba America Medical Systems, In.C, from to . As of , FDA records show no recalls naming K913798.

Clearance record

Decision date
Received
(219 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Toshiba America Medical Systems, In.C 2441 Michelle Dr., Tustin CA
510(k) summary
Summary
Third party review
No

Clearances, product code ITX

Trailing 12 months
6 clearances under product code ITX in the twelve months to November 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code ITX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20262
September 20261
October 20260
November 20260