Cleared Traditional

K083734 - AXXENT SURFACE APPLICATOR, MODEL 710257

K083734 is an FDA 510(k) clearance for AXXENT SURFACE APPLICATOR, manufactured by Xoft, Inc.. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K083734 · Xoft, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
57d
Days
Class 2
Risk

K083734 is an FDA 510(k) clearance for the AXXENT SURFACE APPLICATOR, MODEL 710257. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Xoft, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 11, 2009 after a review of 57 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 - K083734

510(k) Number K083734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2008
Decision Date February 11, 2009
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
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 48
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K083734.
AXXENT RADIATION SHIELD - RIGID
K111299 · Xoft, an Icad Company · Jul 2011
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 VAGINAL APPLICATOR
K072616 · Xoft, Inc. · May 2008
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
K072683 · Xoft, Inc. · Feb 2008
SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM
K063456 · Topex, Inc. · Jan 2007
K083734 · AXXENT SURFACE APPLICATOR, MODEL 710257
Download PDF FDA Summary Xoft, Inc.