Cleared Traditional

K050843 - AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

K050843 is an FDA 510(k) clearance for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM, 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 265-day FDA review.

K050843 · Xoft, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
265d
Days
Class 2
Risk

K050843 is an FDA 510(k) clearance for the AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Xoft, Inc. (Fremont, US). The FDA issued a Cleared decision on December 22, 2005 after a review of 265 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K050843

510(k) Number K050843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 01, 2005
Decision Date December 22, 2005
Days to Decision 265 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
158d slower than avg
Panel avg: 107d · This submission: 265d
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 K050843.
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
INTRABEAM SYSTEM
K051055 · Carl Zeiss Surgical GmbH · May 2005
PHOTON RADIOSURGERY SYSTEM (PRS)
K992577 · Photoelectron Corporation · Sep 1999
PHOTON RADIOSURGERY SYSTEM PRS400
K980526 · Pec Photoelectron Corp. · Jul 1998
K050843 · AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Download PDF FDA Summary Xoft, Inc.