Cleared Traditional

K111299 - AXXENT RADIATION SHIELD - RIGID

K111299 is an FDA 510(k) clearance for AXXENT RADIATION SHIELD - RIGID, manufactured by Xoft, an Icad Company. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K111299 · Xoft, an Icad Company · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
72d
Days
Class 2
Risk

K111299 is an FDA 510(k) clearance for the AXXENT RADIATION SHIELD - RIGID. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Xoft, an Icad Company (Sunnyvale, US). The FDA issued a Cleared decision on July 20, 2011 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K111299

510(k) Number K111299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2011
Decision Date July 20, 2011
Days to Decision 72 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 107d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAD Device Classification - Class 2, Special Controls

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAD System, Therapeutic, X-ray

All 43
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K111299.
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
K122951 · Icad, Inc. · Jan 2013
INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
K121653 · Carl Zeiss Meditec, Inc. · Dec 2012
INTRABEAM NEEDLE APPLICATOR
K110590 · Carl Zeiss Surgical GmbH · Apr 2012
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
K090584 · Carl Zeiss Surgical GmbH · Nov 2009
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
K090914 · Xoft, Inc. · Jul 2009
AXXENT SURFACE APPLICATOR, MODEL 710257
K083734 · Xoft, Inc. · Feb 2009
K111299 · AXXENT RADIATION SHIELD - RIGID
Download PDF FDA Summary Xoft, an Icad Company