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

Programmer, Changer, Film/Cassette, Radiographic

21 CFR 892.1870 / Radiology
FDA source (opens on fda.gov)

IZP is the FDA product code for Programmer, Changer, Film/Cassette, Radiographic, a class II device type, regulated under 21 CFR 892.1870. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IZP
Device name
Programmer, Changer, Film/Cassette, Radiographic
Regulation
21 CFR 892.1870
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
10
Ingested recalls
0

Clearances, product code IZP

By decision year
10 clearances under product code IZP with a decision year between 1984 and 1993, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code IZP by decision year
YearClearances
19844
19851
19881
19902
19911
19931

Applicants with the most clearances

Product code IZP
Applicants holding the most 510(k) clearances under product code IZP
ApplicantClearances
Elema-Schonander, Inc.4
Cgr Medical Corp.1
Changer Service & Engineering, Inc.1
Mallinckrodt Group, Inc.1
Medrad, Inc.1
Philips North America LLC1
Sybron Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code