510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
IWLClass II

System, Radiation Therapy, Neutron, Medical

21 CFR 892.5300 / Radiology
FDA source (opens on fda.gov)

IWL is the FDA product code for System, Radiation Therapy, Neutron, Medical, a class II device type, regulated under 21 CFR 892.5300. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IWL
Device name
System, Radiation Therapy, Neutron, Medical
Regulation
21 CFR 892.5300
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
4
Ingested recalls
0

Clearances, product code IWL

By decision year
4 clearances under product code IWL with a decision year between 1981 and 2007, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IWL by decision year
YearClearances
19812
19851
20071

Applicants with the most clearances

Product code IWL
Applicants holding the most 510(k) clearances under product code IWL
ApplicantClearances
The Cyclotron Corp.2
Medcyc. Corp.1
Northern Illinois Univ. Outreach1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code IWL.