Cleared Special

K041807 - LUNG CAR 1.1 (FDA 510(k) Clearance)

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

K041807 · Medicsight · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
16d
Days
Class 2
Risk

K041807 is an FDA 510(k) clearance for the LUNG CAR 1.1. Classified as Lung Computed Tomography System, Computer-aided Detection (product code OEB), Class II - Special Controls.

Submitted by Medicsight (London, GB). The FDA issued a Cleared decision on July 22, 2004 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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.

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Submission Details

510(k) Number K041807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2004
Decision Date July 22, 2004
Days to Decision 16 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OEB Lung Computed Tomography System, Computer-aided Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Chest And Highlight Potential Nodules That The Radiologist Should Review. A Computer Aided Diagnosis, Lung Computed Tomography System Is A Class 3 Device Under Product Code Nrr.
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 - OEB Lung Computed Tomography System, Computer-aided Detection

All 18
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K203258 · Siemens Healthcare GmbH · Mar 2021