510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013229Substantially Equivalent

Liferay Fw Mammo Cassette, Liferay Kw Mammo Casette

Ferrania USA, Inc., Weatherford OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013229 is the FDA 510(k) clearance record for LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE, a class II device, cleared for Ferrania USA, Inc. on under FDA product code IXA (Cassette, Radiographic Film). FDA records list one 510(k) clearance for Ferrania USA, Inc. As of , FDA records show no recalls naming K013229.

Clearance record

Decision date
Received
(15 days to decision)
Product code
IXA Cassette, Radiographic Film
Regulation
21 CFR 892.1850
Device class
Class II
Review panel
Radiology
Applicant
Ferrania USA, Inc. 2700 E. Frontage Rd., Weatherford OK
510(k) summary
Summary
Third party review
Yes

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