510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K111299Substantially Equivalent

Axxent Radiation Shield - Rigid

Xoft, an Icad Company, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111299 is the FDA 510(k) clearance record for AXXENT RADIATION SHIELD - RIGID, a class II device, cleared for Xoft, an Icad Company on under FDA product code JAD (System, Therapeutic, X-Ray). FDA records list one 510(k) clearance for Xoft, an Icad Company. As of , FDA records show no recalls naming K111299.

Clearance record

Decision date
Received
(72 days to decision)
Product code
JAD System, Therapeutic, X-Ray
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Xoft, an Icad Company 345 Potrero Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAD

Trailing 12 months
1 clearance under product code JAD in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260