Cleared Traditional

K163281 - FastStroke

K163281 is an FDA 510(k) clearance for FastStroke, manufactured by Gef Medical Systems Scs. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K163281 · Gef Medical Systems Scs · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
66d
Days
Class 2
Risk

K163281 is an FDA 510(k) clearance for the FastStroke. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Gef Medical Systems Scs (Buc, FR). The FDA issued a Cleared decision on January 26, 2017 after a review of 66 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 Gef Medical Systems Scs devices

FDA 510(k) Submission Details - K163281

510(k) Number K163281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date January 26, 2017
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 646
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K163281.
syngo. CT Neuro Perfusion
K163284 · Siemens Medical Solutions USA, Inc. · Mar 2017
syngo.CT Extended Functionality
K163341 · Siemens Medical Solutions USA, Inc. · Feb 2017
Aquilion Lightning, TSX-036A/1, V8.4
K170019 · Toshibamedical Systems Corporation · Feb 2017
Somatom Confidence ® RT Pro
K162302 · Siemens Medical Solutions USA, Inc. · Dec 2016
Revolution CT
K163213 · Ge Medical Systems, LLC · Dec 2016
Vitrea CT Dual Energy Image View
K161157 · Vital Images, Inc. · Nov 2016