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

Device, Beam Limiting, Teletherapy, Radionuclide

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

IWD is the FDA product code for Device, Beam Limiting, Teletherapy, Radionuclide, a class II device type, regulated under 21 CFR 892.5750. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
IWD
Device name
Device, Beam Limiting, Teletherapy, 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
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code IWD

By decision year
1 clearance under product code IWD with a decision year between 1997 and 1997, 1997 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IWD by decision year
YearClearances
19971

Applicants with the most clearances

Product code IWD
Applicants holding the most 510(k) clearances under product code IWD
ApplicantClearances
Theratronics, 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 IWD.