Cleared Traditional

K171467 - BioZorb Marker GOLD / LP Marker GOLD

K171467 is the FDA 510(k) clearance for BioZorb Marker GOLD / LP Marker GOLD by Focal Therapeutics. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K171467 · Focal Therapeutics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
175d
Days
Class 2
Risk

K171467 is an FDA 510(k) clearance for the BioZorb Marker GOLD / LP Marker GOLD. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Focal Therapeutics (Sunnyvale, US). The FDA issued a Cleared decision on November 9, 2017 after a review of 175 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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.

View all Focal Therapeutics devices

Submission Details

510(k) Number K171467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2017
Decision Date November 09, 2017
Days to Decision 175 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
68d slower than avg
Panel avg: 107d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 304
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K171467.
ThinkQA
K180106 · Dosisoft · Mar 2018
ARIA Radiation Therapy Management
K173838 · Varian Medical Systems, Inc. · Jan 2018
LumiCoil Platinum Fiducial Marker
K173251 · Boston Scientific Corporation · Dec 2017
VitalBeam
K172013 · Varian Medical Systems, Inc. · Jul 2017
TrueBeam, TrueBeam STx, Edge
K171733 · Varian Medical Systems, Inc. · Jul 2017
Halcyon
K170817 · Varian Medical Systems, Inc. · Jun 2017