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510(k) K033412

MEDICLUNG, RELEASE 1 by Medicsight — Product Code OEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2003
Date Received
October 27, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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.

Other clearances by Medicsight

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  • K032823 — MEDICHEART, MODEL RELEASE 1 (November 10, 2003)
  • K033102 — MEDIC COLON MODEL, RELEASE 1 (November 5, 2003)

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