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

Source, Calibration, Sealed, Nuclear

21 CFR 892.1400 / Radiology
FDA source (opens on fda.gov)

IXD is the FDA product code for Source, Calibration, Sealed, Nuclear, a class I device type, regulated under 21 CFR 892.1400. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IXD
Device name
Source, Calibration, Sealed, Nuclear
Regulation
21 CFR 892.1400
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
2
Ingested recalls
0

Clearances, product code IXD

By decision year
2 clearances under product code IXD with a decision year between 1981 and 1985, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IXD by decision year
YearClearances
19811
19851

Applicants with the most clearances

Product code IXD
Applicants holding the most 510(k) clearances under product code IXD
ApplicantClearances
Amersham Corp.1
Syncor Intl. Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code