Cleared Traditional

HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION (K964746) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964746 · GE Medical Systems · Radiology device
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Jan 1997
Decision
59d
Days
Class 2
Risk

K964746 is an FDA 510(k) clearance for the HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 59 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 GE Medical Systems devices

Submission Details

510(k) Number K964746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1996
Decision Date January 24, 1997
Days to Decision 59 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 427
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K964746.
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K970606 · GE Medical Systems · Apr 1997
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
K965004 · Siemens Medical Solutions USA, Inc. · Mar 1997
SOMATOM PLUS 4 CT SCANNER
K964747 · Siemens Medical Solutions USA, Inc. · Feb 1997
MOBILE CT PROSPEED FAMILY
K963896 · GE Medical Systems · Dec 1996
CT PROSPEED CT/I
K961055 · GE Medical Systems · Jun 1996
REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A
K950972 · Toshiba America Medical Systems, In.C · Apr 1996