Cleared Traditional

CT PROSPEED CT/I (K961055) - FDA 510(k) Clearance

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

K961055 · GE Medical Systems · Radiology device
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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

Submission Details

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.

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 K961055.
SOMATOM PLUS 4 CT SCANNER
K964747 · Siemens Medical Solutions USA, Inc. · Feb 1997
HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION
K964746 · GE Medical Systems · Jan 1997
MOBILE CT PROSPEED FAMILY
K963896 · GE Medical Systems · Dec 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
PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM
K955268 · Philips Medical Systems (Cleveland), Inc. · Jan 1996