Cleared Special

K033374 - LUNGCARE CT SOFTWARE PACKAGE WITH EXTEN...

K033374 is the FDA 510(k) clearance for LUNGCARE CT SOFTWARE PACKAGE WITH EXTEN... by Siemens AG Medical Solutions. It is a Class 2 Radiology device (product code OEB) cleared through the Special 510(k) pathway after a 15-day FDA review.

K033374 · Siemens AG Medical Solutions · Radiology device
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Nov 2003
Decision
15d
Days
Class 2
Risk

K033374 is an FDA 510(k) clearance for the LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY. Classified as Lung Computed Tomography System, Computer-aided Detection (product code OEB), Class II - Special Controls.

Submitted by Siemens AG Medical Solutions (Forchheim, DE). The FDA issued a Cleared decision on November 6, 2003 after a review of 15 days - a notably fast clearance cycle.

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

View all Siemens AG Medical Solutions devices

Submission Details

510(k) Number K033374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2003
Decision Date November 06, 2003
Days to Decision 15 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
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. Third-party reviewed.

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 Consultant

Tuv America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.