Cleared Special

K041807 - LUNG CAR 1.1

K041807 is an FDA 510(k) clearance for LUNG CAR 1.1, manufactured by Medicsight. The device is a Class 2 Radiology device with product code OEB cleared through the Special 510(k) pathway after a 16-day FDA review.

K041807 · Medicsight · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K041807

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

OEB Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (OEB) and FDA review panel - the closest regulatory comparables to K041807.
IMAGECHECKER CT CAD SOFTWARE SYSTEM
K043617 · Hologic, Inc. · Dec 2007
SYNGO LUNG CAD
K063877 · Siemens Medical Solutions USA, Inc. · Oct 2006
ADVANCED LUNG ANALYSIS II
K042694 · GE Medical Systems · Nov 2004
IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
K041380 · R2 Technology, Inc. · Jun 2004
MEDICLUNG, RELEASE 1
K033412 · Medicsight · Dec 2003
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K033374 · Siemens AG Medical Solutions · Nov 2003
K041807 · LUNG CAR 1.1
Download PDF FDA Summary Medicsight