Cleared Traditional

K964746 - HISPEED CT/I WITH PERFORMIX TUBE AND WA...

K964746 is an FDA 510(k) clearance for HISPEED CT/I WITH PERFORMIX TUBE AND WA..., manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K964746 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K964746

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.

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 639
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K964746.
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
K965004 · Siemens Medical Solutions USA, Inc. · Mar 1997
ANATOM 2000
K964890 · Analogic Corp. · Mar 1997
SOMATOM PLUS 4 CT SCANNER
K964747 · Siemens Medical Solutions USA, Inc. · Feb 1997
XRT-7.0
K964583 · Elscint, Inc. · Jan 1997
PHILIPS TOMOSCAN AV EXPANDER UPGRADE
K964318 · Philips Medical Systems North America, Inc. · Jan 1997
MOBILE CT PROSPEED FAMILY
K963896 · GE Medical Systems · Dec 1996