Cleared Traditional

GE VANTAGE PET NEURO SOFTWARE (K062393) - FDA 510(k) Clearance

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

K062393 · Ge Healthcare · Radiology device
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Optimized for regulatory review, auditing and printing
Sep 2006
Decision
16d
Days
Class 2
Risk

K062393 is an FDA 510(k) clearance for the GE VANTAGE PET NEURO SOFTWARE. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Healthcare (Waukesha, US). The FDA issued a Cleared decision on September 1, 2006 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Ge Healthcare devices

Submission Details

510(k) Number K062393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2006
Decision Date September 01, 2006
Days to Decision 16 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 171
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K062393.
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BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
K071068 · Siemens Medical Solutions USA, Inc. · May 2007
FULLCARD ANALYSIS
K061587 · Ge Healthcare · Jun 2006
BIOGRAPH 64 AND BIOGRAPH 40
K060631 · Siemens Medical Solutions USA, Inc. · Mar 2006
BIOGRAPH 6
K060060 · Siemens Medical Solutions USA, Inc. · Feb 2006