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510(k) K033374

LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY by Siemens AG Medical Solutions — Product Code OEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2003
Date Received
October 22, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Lung Computed Tomography System, Computer-Aided Detection
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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.

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Other clearances for product code OEB

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  • K221612 — ClearRead CT (December 5, 2022)
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  • K201501 — Veolity (February 23, 2021)
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  • K193216 — syngo.CT Lung CAD (March 9, 2020)