Cleared Traditional

K100637 - SYNGO.CT CORONARY ANALYSIS

K100637 is an FDA 510(k) clearance for SYNGO.CT CORONARY ANALYSIS, manufactured by Siemens AG Medical Solutions. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K100637 · Siemens AG Medical Solutions · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
82d
Days
Class 2
Risk

K100637 is an FDA 510(k) clearance for the SYNGO.CT CORONARY ANALYSIS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens AG Medical Solutions (Forchheim, Bavaria, DE). The FDA issued a Cleared decision on May 26, 2010 after a review of 82 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.

FDA 510(k) Submission Details - K100637

510(k) Number K100637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2010
Decision Date May 26, 2010
Days to Decision 82 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
25d faster than avg
Panel avg: 107d · This submission: 82d
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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

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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K100637 · SYNGO.CT CORONARY ANALYSIS
Download PDF FDA Summary Siemens AG Medical So…