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

System, Applicator, Radionuclide, Manual

21 CFR 892.5650 / Radiology
FDA source (opens on fda.gov)

IWJ is the FDA product code for System, Applicator, Radionuclide, Manual, a class I device type, regulated under 21 CFR 892.5650. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
IWJ
Device name
System, Applicator, Radionuclide, Manual
Regulation
21 CFR 892.5650
Device class
Class I
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
36
Ingested recalls
11

Clearances, product code IWJ

By decision year
36 clearances under product code IWJ with a decision year between 1980 and 2001, 1989 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code IWJ by decision year
YearClearances
19802
19811
19831
19851
19873
19895
19902
19912
19923
19931
19943
19951
19963
19972
19985
20011

Applicants with the most clearances

Product code IWJ
Applicants holding the most 510(k) clearances under product code IWJ
ApplicantClearances
Mick Radio-Nuclear Instruments, Inc.9
Best Industries4
Avid N.I.T., Inc.3
Amersham Corp.2
Argon Medical Devices, Inc2
American Heyer Schulte1
Best Assoc. Corp.1
Cook Inc.1
Duke University Medical Center1
Esi1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order