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510(k) K192829

Demetra BDEM-01 Dermatoscope by Barco N.V. — Product Code PSN

K192829 is an FDA 510(k) premarket notification submitted by Barco N.V. for the device "Demetra BDEM-01 Dermatoscope". The FDA issued a decision of Substantially Equivalent on December 13, 2019. The device falls under product code PSN (Light Based Imaging), a Class II device regulated under 21 CFR 878.4580. Barco N.V. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2019
Date Received
October 2, 2019
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

Other clearances by Barco N.V.

  • K243307 — LCD Monitor (MDEC-2523) (December 13, 2024)
  • K242008 — Coronis OneLook (August 2, 2024)
  • K233693 — Nio Color 8MP (MDNC-8132) (December 11, 2023)
  • K230520 — Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) (March 21, 2023)
  • K213957 — Demetra Dermatoscope BDEM-01 (March 11, 2022)
  • K203364 — MDPC-8127 (April 15, 2021)
  • K201408 — Demetra Analytics Toolkit (February 18, 2021)
  • K203106 — Nio Fusion 12MP (MDNC-12130) (November 10, 2020)
  • K191845 — Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workfl (September 6, 2019)
  • K173381 — Nexxis OR (February 22, 2018)

Other clearances for product code PSN

  • K230448 — DeepX DermoSight Dermatoscope (May 17, 2023)
  • K213957 — Demetra Dermatoscope BDEM-01 (March 11, 2022)
  • K201408 — Demetra Analytics Toolkit (February 18, 2021)
  • K180162 — VivaScope System (May 3, 2018)
  • 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)

FDA data resources