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

Device, Spot-Film

21 CFR 892.1670 / Radiology
FDA source (opens on fda.gov)

IXL is the FDA product code for Device, Spot-Film, a class II device type, regulated under 21 CFR 892.1670. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
IXL
Device name
Device, Spot-Film
Regulation
21 CFR 892.1670
Device class
Class II
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
13
Ingested recalls
3

Clearances, product code IXL

By decision year
13 clearances under product code IXL with a decision year between 1980 and 2011, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IXL by decision year
YearClearances
19801
19811
19841
19882
19902
19921
19942
19951
19971
20111

Applicants with the most clearances

Product code IXL
Applicants holding the most 510(k) clearances under product code IXL
ApplicantClearances
Applied X-Ray Technologies, Inc.2
GE Healthcare2
Philips North America LLC2
Rms Div.2
Continental X-Ray Corp.1
Eastman Kodak Company1
Fischer Imaging Corp.1
General Electric Co.1
Machlett Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code