Cleared Traditional

K073081 - JET SOFTWARE FOR EXCELART VANTAGE ATLAS...

K073081 is the FDA 510(k) clearance for JET SOFTWARE FOR EXCELART VANTAGE ATLAS... by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K073081 · Toshiba America Medical Systems, In.C · Radiology device
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Nov 2007
Decision
20d
Days
Class 2
Risk

K073081 is an FDA 510(k) clearance for the JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on November 21, 2007 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K073081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2007
Decision Date November 21, 2007
Days to Decision 20 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
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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

Regulatory Technology Services, LLC
MARK JOB

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.

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