510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971431Substantially Equivalent

Umi X-Ray Film Cassette

Umi Intl., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971431 is the FDA 510(k) clearance record for UMI X-RAY FILM CASSETTE, a class II device, cleared for Umi Intl. on under FDA product code IXA (Cassette, Radiographic Film). FDA records list one 510(k) clearance for Umi Intl. As of , FDA records show no recalls naming K971431.

Clearance record

Decision date
Received
(33 days to decision)
Product code
IXA Cassette, Radiographic Film
Regulation
21 CFR 892.1850
Device class
Class II
Review panel
Radiology
Applicant
Umi Intl. 18 Roberts Dr., Bedford MA
510(k) summary
Statement
Third party review
No

Clearances, product code IXA

Trailing 12 months

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

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