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510(k) K201408

Demetra Analytics Toolkit by Barco N.V. — Product Code PSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2021
Date Received
May 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Imaging
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Emission and collection of light to create an image for medical purposes

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  • K080788 — VIVASCOPE SYSTEM, MODEL 1500, 3000 (September 17, 2008)
  • K062736 — SIASCOPE V (September 14, 2007)
  • K040171 — MICRODERM, MODEL/VERSION 3.5 (June 8, 2004)
  • K023729 — SIASCOPE II (February 3, 2003)
  • K011273 — SI ASCOPE (February 20, 2002)