Cleared Traditional

K003639 - VITREA 2 CT PERFUSION OPTION

K003639 is the FDA 510(k) clearance for VITREA 2 CT PERFUSION OPTION by Vital Images, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K003639 · Vital Images, Inc. · Radiology device
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Jan 2001
Decision
60d
Days
Class 2
Risk

K003639 is an FDA 510(k) clearance for the VITREA 2 CT PERFUSION OPTION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Vital Images, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 23, 2001 after a review of 60 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 Vital Images, Inc. devices

Submission Details

510(k) Number K003639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2000
Decision Date January 23, 2001
Days to Decision 60 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
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 581
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K003639.
E-Z EM PERCUPUMP 2001 CT INJECTOR
K011160 · E-Z-Em, Inc. · May 2001
GE CT-PET SYSTEM
K010641 · Ge Medical Systems, Inc. · Mar 2001
CT PERFUSION 2
K010042 · General Electric Co. · Jan 2001
V SCORE WITH AUTO GATE MODEL TBD
K003230 · Vital Images, Inc. · Dec 2000
CT CORD IQ OPTION 1.0
K003408 · GE Medical Systems · Nov 2000
SOMATOM SMILE
K003152 · Siemens Medical Solutions USA, Inc. · Oct 2000