510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894632Substantially Equivalent

Model Ssh-140A Ultrasound Imaging System

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

K894632 is the FDA 510(k) clearance record for MODEL SSH-140A ULTRASOUND IMAGING SYSTEM, a class II device, cleared for Toshiba America Medical Systems, In.C on under FDA product code DXK (Echocardiograph). FDA records list 146 510(k) clearances for Toshiba America Medical Systems, In.C, from to . As of , FDA records show no recalls naming K894632.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DXK Echocardiograph
Regulation
21 CFR 870.2330
Device class
Class II
Review panel
Cardiovascular
Applicant
Toshiba America Medical Systems, In.C 2441 Michelle Dr., Tustin CA
Third party review
No

Clearances, product code DXK

Trailing 12 months

FDA records hold no clearances under product code DXK in the trailing twelve months.

FDA records show no clearances under product code DXK in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXK, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260