510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853115Substantially Equivalent

Sonolayer S, Ssh-60A/sds-60A

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

K853115 is the FDA 510(k) clearance record for SONOLAYER S, SSH-60A/SDS-60A, a class II device, cleared for Toshiba Medical Systems on under FDA product code DXK (Echocardiograph). FDA records list 54 510(k) clearances for Toshiba Medical Systems, from to . As of , FDA records show no recalls naming K853115.

Clearance record

Decision date
Received
(231 days to decision)
Product code
DXK Echocardiograph
Regulation
21 CFR 870.2330
Device class
Class II
Review panel
Cardiovascular
Applicant
Toshiba Medical Systems 2441 Michelle, 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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260