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

Assembly, Tube Housing, X-Ray, Diagnostic

21 CFR 892.1760 / Radiology
FDA source (opens on fda.gov)

ITY is the FDA product code for Assembly, Tube Housing, X-Ray, Diagnostic, a class I device type, regulated under 21 CFR 892.1760. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
ITY
Device name
Assembly, Tube Housing, X-Ray, Diagnostic
Regulation
21 CFR 892.1760
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
4

Clearances, product code ITY

By decision year
40 clearances under product code ITY with a decision year between 1976 and 2000, 1992 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code ITY by decision year
YearClearances
19761
19771
19782
19812
19833
19841
19863
19873
19882
19892
19902
19916
19928
19933
20001

Applicants with the most clearances

Product code ITY
Applicants holding the most 510(k) clearances under product code ITY
ApplicantClearances
Inmark Corp.4
Shimadzu Medical Systems4
Comet Ltd. C/O Radiology Resources, Inc.3
X-Ray Tube Corp.3
General Electric Co.2
Mrx-Ray Tube Corp.2
Siemens Corp.2
Absolute X-Ray Corp.1
Advantech Corporation1
American Canadian Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order