510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905152Substantially Equivalent

Remote Controlled X-Ray Diag. Rsz-200

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

K905152 is the FDA 510(k) clearance record for REMOTE CONTROLLED X-RAY DIAG. RSZ-200, a class II device, cleared for Shimadzu Medical Systems on under FDA product code IXR (Table, Radiographic, Tilting). FDA records list 90 510(k) clearances for Shimadzu Medical Systems, from to . As of , FDA records show no recalls naming K905152.

Clearance record

Decision date
Received
(26 days to decision)
Product code
IXR Table, Radiographic, Tilting
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Shimadzu Medical Systems 101 W. Walnut St., Gardena CA
Third party review
No

Clearances, product code IXR

Trailing 12 months

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

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