AXXENT RADIATION SHIELD - RIGID— 510(k) K111299

Substantially Equivalent

Xoft, an Icad Company

FDA 510(k) clearance K111299 for AXXENT RADIATION SHIELD - RIGID, Substantially Equivalent on 2011-07-20. Applicant: Xoft, an Icad Company. Device class: 2.

Clearance details

Applicant
Xoft, an Icad Company
Product code
Code JAD
Device class
Class 2
Regulation
21 CFR 892.5900
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunnyvale, CA, US
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