Cleared Traditional

TRAXYLOC-1 SYSTEM (K050663) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050663 · Traxyz Medical, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
24d
Days
Class 2
Risk

K050663 is an FDA 510(k) clearance for the TRAXYLOC-1 SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Traxyz Medical, Inc. (Westborough, US). The FDA issued a Cleared decision on April 8, 2005 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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.

View all Traxyz Medical, Inc. devices

Submission Details

510(k) Number K050663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2005
Decision Date April 08, 2005
Days to Decision 24 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 - IZH System, X-ray, Mammographic

All 18
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K050663.
SMART FINDER
K203509 · Ims Giotto S.P.A. · Jul 2021
Affirm Contrast Biopsy
K202294 · Hologic, Inc. · Oct 2020
Biopsy Positioner
K191495 · Fujifilm Corporation · Jul 2019
OPDIMA
K003945 · Siemens Medical Solutions USA, Inc. · Feb 2001
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · Siemens Medical Solutions USA, Inc. · May 1997
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · GE Medical Systems · Jan 1996