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

System, Rebreathing, Radionuclide

21 CFR 892.1390 / Radiology
FDA source (opens on fda.gov)

IYT is the FDA product code for System, Rebreathing, Radionuclide, a class II device type, regulated under 21 CFR 892.1390. As of , FDA records hold 49 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IYT
Device name
System, Rebreathing, Radionuclide
Regulation
21 CFR 892.1390
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
49
Ingested recalls
0

Clearances, product code IYT

By decision year
49 clearances under product code IYT with a decision year between 1978 and 2026, 1985 the highest year at 14.
Show the numbers
510(k) clearances under FDA product code IYT by decision year
YearClearances
19782
19812
19822
19842
198514
19867
19872
19883
19906
19914
19921
19952
20201
20261

Applicants with the most clearances

Product code IYT
Applicants holding the most 510(k) clearances under product code IYT
ApplicantClearances
Medipart Jerry Alexander23
Amici, Inc.4
Medi Nuclear Corp., Inc.3
Mallinckrodt Critical Care2
Vital Signs, Inc.2
Amici, Inc.1
Atomic Products Corp.1
Cadema Medical Products, Inc.1
Cis-Us, Inc.1
Cyclomedica Australia Pty Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code