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

System, Imaging, X-Ray, Electrostatic

21 CFR 892.1630 / Radiology
FDA source (opens on fda.gov)

IXK is the FDA product code for System, Imaging, X-Ray, Electrostatic, a class II device type, regulated under 21 CFR 892.1630. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IXK
Device name
System, Imaging, X-Ray, Electrostatic
Regulation
21 CFR 892.1630
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
14
Ingested recalls
0

Clearances, product code IXK

By decision year
14 clearances under product code IXK with a decision year between 1976 and 2011, 1992 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code IXK by decision year
YearClearances
19761
19851
19923
19931
19942
20001
20021
20031
20041
20071
20111

Applicants with the most clearances

Product code IXK
Applicants holding the most 510(k) clearances under product code IXK
ApplicantClearances
FUJIFILM Healthcare Americas Corporation4
Agfa Corp.2
Canon Medical Components U.S.A., Inc.1
Electron Jsco.1
Orex Computed Radiography, Ltd.1
Orion Corporation Soredex1
Portavision Medical, LLC1
Siemens Medical Solutions USA, Inc.1
Xeroradiography1
Xerox Medical Systems1

Companies listing this code with FDA

Companies whose registered establishments list this code

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