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

Film, Radiographic

21 CFR 892.1840 / Radiology
FDA source (opens on fda.gov)

IWZ is the FDA product code for Film, Radiographic, a class I device type, regulated under 21 CFR 892.1840. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
IWZ
Device name
Film, Radiographic
Regulation
21 CFR 892.1840
Device class
Class I
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
34
Ingested recalls
13

Clearances, product code IWZ

By decision year
34 clearances under product code IWZ with a decision year between 1977 and 1997, 1980 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code IWZ by decision year
YearClearances
19772
19792
198010
19812
19832
19846
19851
19863
19891
19921
19932
19951
19971

Applicants with the most clearances

Product code IWZ
Applicants holding the most 510(k) clearances under product code IWZ
ApplicantClearances
Eastman Kodak Company17
Cea America Corp.4
3M Company2
E.I. Dupont de Nemours & Co., Inc.2
Belmont Equipment Corp.1
Burkhart Roentgen Intl., Inc.1
Fr Medical/Fr Chemicals1
Hope Industries, Inc.1
India-America Trading Co.1
Parexel Intl. Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order