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LungCARE CT Software Package

by Siemens Medical Solutions USA, Inc.

510(k) K022013

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022013 Date16 Jul 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JAK
Device class
Class II
Regulation
21 CFR Part 892.1750
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LungCARE CT Software Package is a Computer-Aided Detection (CAD) system for lung computed tomography, designed to analyze CT volume datasets. It combines digital image processing tools—including Maximum Intensity Projection (MIP), Multiplanar Reformation (MPR), Surface-Shaded Display (SSD), and Volume Rendering Technique (VRT)—with automated evaluation and reporting functions. The software assists radiologists in identifying and characterizing lung lesions, enabling volumetric measurements to monitor progression or regression over time. Its primary purpose is to enhance diagnostic accuracy and workflow efficiency in pulmonary imaging.

This software package is intended for use in radiology departments equipped with CT scanners and workstations capable of processing digital imaging data. It is supplied as a standalone software solution, requiring integration with existing CT imaging systems for data input. The device is not sterile and is designed for reusable institutional use under controlled IT environments. No specific MRI safety classifications or size variations are noted in the regulatory submission, and its FDA 510(k) clearance (K022013) under the Radiology Advisory Committee confirms compliance with U.S. regulatory requirements for substantially equivalent performance to predicate devices.

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