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510(k) K121418

PLANMED VERITY by Planmed OY — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2013
Date Received
May 11, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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  • K192317 — Planmed Clarity 2D and Clarity S (October 23, 2020)
  • K180918 — Planmed Verity (November 30, 2018)
  • K163328 — Planmed Clarity (December 28, 2017)
  • K143435 — Planmed Verity (May 14, 2015)
  • K121963 — PLANMED NUANCE DIGIGUIDE (November 21, 2012)
  • K042671 — PLANMED SOPHIE NUANCE CLASSIC (November 19, 2004)
  • K021945 — PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) (February 21, 2003)

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