Cleared Traditional

K071513 - INSPACE 4D SOFTWARE PACKAGE WITH EXTEND...

K071513 is an FDA 510(k) clearance for INSPACE 4D SOFTWARE PACKAGE WITH EXTEND..., manufactured by Siemens Medical Solutions. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K071513 · Siemens Medical Solutions · Radiology device
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Optimized for regulatory review, auditing and printing
Jun 2007
Decision
22d
Days
Class 2
Risk

K071513 is an FDA 510(k) clearance for the INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions (Forchheim, DE). The FDA issued a Cleared decision on June 26, 2007 after a review of 22 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 Siemens Medical Solutions devices

FDA 510(k) Submission Details - K071513

510(k) Number K071513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2007
Decision Date June 26, 2007
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 636
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