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

Synchrotron, Medical

21 CFR 892.5050 / Radiology
FDA source (opens on fda.gov)

IWM is the FDA product code for Synchrotron, Medical, a class II device type, regulated under 21 CFR 892.5050. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
IWM
Device name
Synchrotron, Medical
Regulation
21 CFR 892.5050
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
1
Ingested recalls
0

Clearances, product code IWM

By decision year
1 clearance under product code IWM with a decision year between 1988 and 1988, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IWM by decision year
YearClearances
19881

Applicants with the most clearances

Product code IWM
Applicants holding the most 510(k) clearances under product code IWM
ApplicantClearances
Loma Linda University Medical Center1

Companies listing this code with FDA

Companies whose registered establishments list this code

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