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510(k) K193152

Affinity by Hermes Medical Solutions AB — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2020
Date Received
November 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Hermes Medical Solutions AB

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  • K202882 — Affinity (December 23, 2020)
  • K191216 — Voxel Dosimetry™ v1.0 (October 17, 2019)
  • K181468 — Hybrid3D (October 25, 2018)
  • K171719 — Hybrid3D (November 21, 2017)
  • K171681 — Hermes Medical Imaging Suite v5.7 (November 21, 2017)
  • K163687 — OLINDA EXM (July 19, 2017)
  • K163394 — Hybrid3D (May 22, 2017)

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