510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083503Substantially Equivalent

Drad30003/radrex-I

Toshiba America Medical Systems, In.C, Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083503 is the FDA 510(k) clearance record for DRAD30003/RADREX-I, a class II device, cleared for Toshiba America Medical Systems, In.C on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 146 510(k) clearances for Toshiba America Medical Systems, In.C, from to . As of , FDA records show one recall naming K083503.

Clearance record

Decision date
Received
(79 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Toshiba America Medical Systems, In.C 2441 Michelle Dr., Tustin CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code KPR

Trailing 12 months
7 clearances under product code KPR in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20261
October 20260