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

Source, Isotope, Sealed, Gold, Titanium, Platinum

21 CFR 892.5730 / Radiology
FDA source (opens on fda.gov)

IWI is the FDA product code for Source, Isotope, Sealed, Gold, Titanium, Platinum, a class II device type, regulated under 21 CFR 892.5730. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IWI
Device name
Source, Isotope, Sealed, Gold, Titanium, Platinum
Regulation
21 CFR 892.5730
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
6
Ingested recalls
0

Clearances, product code IWI

By decision year
6 clearances under product code IWI with a decision year between 1986 and 1998, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IWI by decision year
YearClearances
19861
19871
19891
19911
19941
19981

Applicants with the most clearances

Product code IWI
Applicants holding the most 510(k) clearances under product code IWI
ApplicantClearances
Best Industries1
Cis-Us, Inc.1
Medi-Physics Inc. dba Nycomed Amersham Imaging1
Ml Strategies, Inc.1
Nuclear Medicine, Inc.1
Theragenics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code