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510(k) K202300

Optellum Virtual Nodule Clinic, Optellum software, Optellum platform by Optellum, Ltd. — Product Code POK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2021
Date Received
August 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class
Class II
Regulation Number
892.2060
Review Panel
RA
Submission Type

Assist users in characterizing lesions identified on acquired medical images

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