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

Camera, Focal Spot, Radiographic

21 CFR 892.1940 / Radiology
FDA source (opens on fda.gov)

IXH is the FDA product code for Camera, Focal Spot, Radiographic, a class I device type, regulated under 21 CFR 892.1940. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IXH
Device name
Camera, Focal Spot, Radiographic
Regulation
21 CFR 892.1940
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code IXH

By decision year
2 clearances under product code IXH with a decision year between 1985 and 2002, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IXH by decision year
YearClearances
19851
20021

Applicants with the most clearances

Product code IXH
Applicants holding the most 510(k) clearances under product code IXH
ApplicantClearances
Mbf Sales, LLC1
Victoreen, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code