510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915413Substantially Equivalent

Cat-250B

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

K915413 is the FDA 510(k) clearance record for CAT-250B, a class II device, cleared for Toshiba America Medical Systems, In.C on under FDA product code IZZ (Table, Radiographic, Non-Tilting, Powered). FDA records list 146 510(k) clearances for Toshiba America Medical Systems, In.C, from to . As of , FDA records show no recalls naming K915413.

Clearance record

Decision date
Received
(15 days to decision)
Product code
IZZ Table, Radiographic, Non-Tilting, Powered
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Toshiba America Medical Systems, In.C 2441 Michelle Dr., Tustin CA
510(k) summary
Statement
Third party review
No

Clearances, product code IZZ

Trailing 12 months

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

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