510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903085Substantially Equivalent

Sms-712Na

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

K903085 is the FDA 510(k) clearance record for SMS-712NA, a class II device, cleared for Toshiba America Medical Systems, In.C on under FDA product code GXW (Echoencephalograph). FDA records list 146 510(k) clearances for Toshiba America Medical Systems, In.C, from to . As of , FDA records show no recalls naming K903085.

Clearance record

Decision date
Received
(85 days to decision)
Product code
GXW Echoencephalograph
Regulation
21 CFR 882.1240
Device class
Class II
Review panel
Neurology
Applicant
Toshiba America Medical Systems, In.C 2441 Michelle Dr., Tustin CA
Third party review
No

Clearances, product code GXW

Trailing 12 months

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

FDA records show no clearances under product code GXW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXW, 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