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

Generator, High-Voltage, X-Ray, Diagnostic

21 CFR 892.1700 / Radiology
FDA source (opens on fda.gov)

IZO is the FDA product code for Generator, High-Voltage, X-Ray, Diagnostic, a class I device type, regulated under 21 CFR 892.1700. As of , FDA records hold 163 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
IZO
Device name
Generator, High-Voltage, X-Ray, Diagnostic
Regulation
21 CFR 892.1700
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
163
Ingested recalls
4

Clearances, product code IZO

By decision year
163 clearances under product code IZO with a decision year between 1976 and 1995, 1991 the highest year at 25.
Show the numbers
510(k) clearances under FDA product code IZO by decision year
YearClearances
19762
19776
19781
19794
19806
19815
19823
19831
19841
19855
19866
19876
198821
19899
199010
199125
199211
199315
199412
199514

Applicants with the most clearances

Product code IZO
Applicants holding the most 510(k) clearances under product code IZO
ApplicantClearances
Fischer Imaging Corp.22
General Electric Co.12
Shimadzu Medical Systems10
Electromed Intl., Ltd.8
Philips North America LLC8
Siemens Corp.6
Continental X-Ray Corp.5
Control-X, Inc.5
Siemens Medical Solutions USA, Inc.5
Varian Canada, Inc.5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order