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

Tube Mount, X-Ray, Diagnostic

21 CFR 892.1770 / Radiology
FDA source (opens on fda.gov)

IYB is the FDA product code for Tube Mount, X-Ray, Diagnostic, a class I device type, regulated under 21 CFR 892.1770. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
IYB
Device name
Tube Mount, X-Ray, Diagnostic
Regulation
21 CFR 892.1770
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
40
Ingested recalls
13

Clearances, product code IYB

By decision year
40 clearances under product code IYB with a decision year between 1978 and 1996, 1988 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code IYB by decision year
YearClearances
19782
19813
19842
19854
19863
19872
19886
19893
19901
19914
19923
19932
19943
19951
19961

Applicants with the most clearances

Product code IYB
Applicants holding the most 510(k) clearances under product code IYB
ApplicantClearances
Fischer Imaging Corp.5
Shimadzu Medical Systems4
Bennett X-Ray Corp.3
Radkor, Inc.3
Acoma Medical Imaging, Inc.2
General Electric Co.2
Medicor USA, Ltd.2
Tecnomed, Inc.2
Wuestec Medical, Inc.2
Continental X-Ray Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order