Cleared Traditional

MX8000 IDT CT SYSTEM (K012009) - FDA 510(k) Clearance

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

K012009 · Marconi Medical Systems, Inc. · Radiology device
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Sep 2001
Decision
78d
Days
Class 2
Risk

K012009 is an FDA 510(k) clearance for the MX8000 IDT CT SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Marconi Medical Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on September 13, 2001 after a review of 78 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 Marconi Medical Systems, Inc. devices

Submission Details

510(k) Number K012009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2001
Decision Date September 13, 2001
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
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 385
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K012009.
LIGHTSPEED 4.0 CT SCANNER SYSTEM
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ADVANCED LUNG ANALYSIS-1
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MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
K012836 · GE Medical Systems · Sep 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