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

Cassette, Radiographic Film

21 CFR 892.1850 / Radiology
FDA source (opens on fda.gov)

IXA is the FDA product code for Cassette, Radiographic Film, a class II device type, regulated under 21 CFR 892.1850. As of , FDA records hold 51 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
IXA
Device name
Cassette, Radiographic Film
Regulation
21 CFR 892.1850
Device class
Class II
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
51
Ingested recalls
1

Clearances, product code IXA

By decision year
51 clearances under product code IXA with a decision year between 1977 and 2008, 1995 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code IXA by decision year
YearClearances
19771
19801
19811
19841
19851
19861
19882
19894
19904
19911
19921
19936
19945
19957
19962
19973
19981
19991
20013
20022
20041
20051
20081

Applicants with the most clearances

Product code IXA
Applicants holding the most 510(k) clearances under product code IXA
ApplicantClearances
Eastman Kodak Company13
E.I. Dupont de Nemours & Co., Inc.6
Dupont Medical Products2
FUJIFILM Healthcare Americas Corporation2
Mci Optonix2
Agfa Corp.1
Cook, Inc.1
Ferrania S.p.A.1
Ferrania USA, Inc.1
Huestis Machine Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order