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510(k) K220477

Cellvizio 100 series system with confocal Miniprobes by Mauna Kea Technologies — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2022
Date Received
February 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Confocal Optical Imaging
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Collection of light signals for visualization of cellular microstructures.

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  • K180270 — Cellvizio 100 Series Systems with Confocal Miniprobes (May 22, 2018)
  • K172844 — Cellvizio 100 Series System with Confocal Miniprobes (December 15, 2017)
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  • K160416 — CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal M (May 20, 2016)
  • K150831 — Cellvizio 100 Series System with Confocal Miniprobes (December 22, 2015)
  • K151593 — Cellvizio 100 Series System with Confocal Miniprobes (October 23, 2015)

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