Cleared Special

MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM (K012836) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012836 · GE Medical Systems · Radiology device
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Sep 2001
Decision
15d
Days
Class 2
Risk

K012836 is an FDA 510(k) clearance for the MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM. 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 September 7, 2001 after a review of 15 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all GE Medical Systems devices

Submission Details

510(k) Number K012836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date September 07, 2001
Days to Decision 15 days
Submission Type Special
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
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 K012836.
CARDIQ FUNCTION
K013422 · GE Medical Systems · Oct 2001
ADVANCED LUNG ANALYSIS-1
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CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
K013214 · Toshiba America Medical Systems, In.C · Oct 2001
IN SPACE 3D
K011447 · Siemens Medical Solutions USA, Inc. · Aug 2001
MX8000 V5.0 CT SYSTEM
K010817 · Philips Medical Systems (Cleveland), Inc. · Jun 2001
CT PERFUSION 2
K010042 · General Electric Co. · Jan 2001