Cleared Traditional

K060903 - IG4 IMAGE GUIDED SYSTEM

K060903 is an FDA 510(k) clearance for IG4 IMAGE GUIDED SYSTEM, 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 38-day FDA review.

K060903 · Veran Medical Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
38d
Days
Class 2
Risk

K060903 is an FDA 510(k) clearance for the IG4 IMAGE GUIDED SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Veran Medical Technologies, Inc. (Nashville, US). The FDA issued a Cleared decision on May 11, 2006 after a review of 38 days - a notably fast clearance 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: 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 Veran Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K060903

510(k) Number K060903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2006
Decision Date May 11, 2006
Days to Decision 38 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
69d faster than avg
Panel avg: 107d · This submission: 38d
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 K060903.
BRILLIANCE VOLUME
K060937 · Philips Medical Systems (Cleveland), Inc. · Jun 2006
CARDIQ FUSION
K061370 · Ge Healthcare · May 2006
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
K061187 · Toshiba America Medical Systems, In.C · May 2006
GE LIGHTSPEED XTRA CT SCANNER SYSTEM
K060052 · Ge Medical Systems, LLC · Apr 2006
ADVANCE VESSEL ANALYSIS II
K060779 · Ge Healthcare · Apr 2006
CT PERFUSION 4
K052839 · Ge Healthcare · Mar 2006