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

System, Radiation Therapy, Radionuclide

21 CFR 892.5750 / Radiology
FDA source (opens on fda.gov)

IWB is the FDA product code for System, Radiation Therapy, Radionuclide, a class II device type, regulated under 21 CFR 892.5750. As of , FDA records hold 48 510(k) clearances under this code, the most recent dated , and 29 recalls.

Classification record

Product code
IWB
Device name
System, Radiation Therapy, Radionuclide
Regulation
21 CFR 892.5750
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
No
Ingested clearances
48
Ingested recalls
29

Clearances, product code IWB

By decision year
48 clearances under product code IWB with a decision year between 1978 and 2025, 2006 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code IWB by decision year
YearClearances
19781
19821
19851
19862
19871
19901
19911
19921
19931
19951
19961
19972
19982
19992
20002
20041
20051
20064
20071
20091
20111
20121
20143
20153
20161
20171
20183
20191
20201
20212
20221
20241
20251

Applicants with the most clearances

Product code IWB
Applicants holding the most 510(k) clearances under product code IWB
ApplicantClearances
Elekta Instrument AB13
Akesis Inc.3
Elekta Solutions AB3
Theratronics, Inc.3
Accuray Incorporated2
Best Theratronics Ltd.2
Mds Nordion2
Xcision Medical Systems, LLC2
Aecl Medical1
American Radiosurgery, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code