Cleared Traditional

K063241 - CSTC-002A

K063241 is the FDA 510(k) clearance for CSTC-002A by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K063241 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
14d
Days
Class 2
Risk

K063241 is an FDA 510(k) clearance for the CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION. 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 November 9, 2006 after a review of 14 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

Submission Details

510(k) Number K063241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2006
Decision Date November 09, 2006
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K063241.
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
K071378 · E-Z-Em, Inc. · Jun 2007
PET VCAR
K063324 · Ge Healthcare · Mar 2007
SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K063762 · Siemens AG Medical Solutions · Jan 2007
MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION
K063184 · Toshiba America Medical Systems, In.C · Nov 2006
TSX-301A, AQUILION ONE CT SYSTEM
K063189 · Toshiba America Medical Systems, In.C · Nov 2006
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
K063029 · E-Z-Em, Inc. · Nov 2006