Cleared Traditional

K072737 - CSCS-001A CALCIUM SCORING PACKAGE

K072737 is an FDA 510(k) clearance for CSCS-001A CALCIUM SCORING PACKAGE, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K072737 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
8d
Days
Class 2
Risk

K072737 is an FDA 510(k) clearance for the CSCS-001A CALCIUM SCORING PACKAGE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on October 5, 2007 after a review of 8 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 Toshiba America Medical Systems, In.C devices

FDA 510(k) Submission Details - K072737

510(k) Number K072737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date October 05, 2007
Days to Decision 8 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
99d faster than avg
Panel avg: 107d · This submission: 8d
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

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.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 731
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K072737.
SYNGO VOLUME PERFUSION-CT BODY
K073373 · Siemens AG Medical Solutions · Dec 2007
CSNP-001A NEURO PACKAGE
K072693 · Toshiba America Medical Systems, In.C · Nov 2007
NEUVIZ SPIRAL CT SCANNER SYSTEM
K072841 · Neusoft Medical Systems Co., Ltd. · Oct 2007
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
K072606 · Toshiba America Medical Systems, In.C · Oct 2007
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
K071806 · Hitachi Medical Systems America, Inc. · Aug 2007
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
K071308 · Neusoft Medical Systems Co., Ltd. · Aug 2007