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

Collimator, Orthovoltage, Therapeutic X-Ray

21 CFR 892.5900 / Radiology
FDA source (opens on fda.gov)

IYI is the FDA product code for Collimator, Orthovoltage, Therapeutic X-Ray, a class II device type, regulated under 21 CFR 892.5900. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IYI
Device name
Collimator, Orthovoltage, Therapeutic X-Ray
Regulation
21 CFR 892.5900
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
2
Ingested recalls
0

Clearances, product code IYI

By decision year
2 clearances under product code IYI with a decision year between 1990 and 1992, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IYI by decision year
YearClearances
19901
19921

Applicants with the most clearances

Product code IYI
Applicants holding the most 510(k) clearances under product code IYI
ApplicantClearances
Consolidated Radiation Services, Inc.1
Victoreen, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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