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

Camera, X-Ray, Fluorographic, Cine Or Spot

21 CFR 892.1620 / Radiology
FDA source (opens on fda.gov)

IZJ is the FDA product code for Camera, X-Ray, Fluorographic, Cine Or Spot, a class II device type, regulated under 21 CFR 892.1620. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
IZJ
Device name
Camera, X-Ray, Fluorographic, Cine Or Spot
Regulation
21 CFR 892.1620
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
12
Ingested recalls
2

Clearances, product code IZJ

By decision year
12 clearances under product code IZJ with a decision year between 1979 and 2003, 1981 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code IZJ by decision year
YearClearances
19791
19801
19813
19851
19881
19901
19921
19951
19971
20031

Applicants with the most clearances

Product code IZJ
Applicants holding the most 510(k) clearances under product code IZJ
ApplicantClearances
Philips North America LLC3
Siemens Corp.2
Canon Medical Components U.S.A., Inc.1
Diversified P.A.1
Fairmontmedical1
Instrumentation Camera, Inc.1
Perkins Electronics Co.1
Perkins Mfg. Co.1
Scientex Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code IZJ.