Cleared Traditional

K091934 - IG4 ENDOBRONCHIAL

K091934 is an FDA 510(k) clearance for IG4 ENDOBRONCHIAL, manufactured by Veran Medical Technologies, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K091934 · Veran Medical Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
155d
Days
Class 2
Risk

K091934 is an FDA 510(k) clearance for the IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 END.... Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Veran Medical Technologies, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 2, 2009 after a review of 155 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Veran Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K091934

510(k) Number K091934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2009
Decision Date December 02, 2009
Days to Decision 155 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
48d slower than avg
Panel avg: 107d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 640
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K091934.
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102259 · VATECH Co., Ltd. · Feb 2011
AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
K093891 · Toshibamedical Systems Corporation · Nov 2010
SYNGO.CT CORONARY ANALYSIS
K100637 · Siemens AG Medical Solutions · May 2010
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
K092747 · Philips Medical Systems (Cleveland), Inc. · Oct 2009
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
K092742 · Neusoft Medical Systems Co., Ltd. · Sep 2009
SYNGO VOLUME PERFUSION-CT BODY
K092013 · Siemens AG Medical Solutions · Jul 2009