510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K143537Substantially Equivalent

Sirius Starmobile tiara

FUJIFILM Healthcare Americas Corporation, Twinsburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143537 is the FDA 510(k) clearance record for Sirius Starmobile tiara, a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K143537.

Clearance record

Decision date
Received
(81 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park, Twinsburg OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZL

Trailing 12 months
7 clearances under product code IZL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20261