Cleared Traditional

K961055 - CT PROSPEED CT/I

K961055 is an FDA 510(k) clearance for CT PROSPEED CT/I, 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 91-day FDA review.

K961055 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
91d
Days
Class 2
Risk

K961055 is an FDA 510(k) clearance for the CT PROSPEED CT/I. 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 June 17, 1996 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Medical Systems devices

FDA 510(k) Submission Details - K961055

510(k) Number K961055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1996
Decision Date June 17, 1996
Days to Decision 91 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
16d faster than avg
Panel avg: 107d · This submission: 91d
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 K961055.
PHILIPS TOMOSCAN AV EXPANDER UPGRADE
K964318 · Philips Medical Systems North America, Inc. · Jan 1997
MOBILE CT PROSPEED FAMILY
K963896 · GE Medical Systems · Dec 1996
SELECT/SP
K961464 · Elscint, Inc. · Jul 1996
REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A
K950972 · Toshiba America Medical Systems, In.C · Apr 1996
PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS
K960635 · Siemens Medical Solutions USA, Inc. · Apr 1996
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX
K955255 · Shimadzu Medical Systems · Feb 1996