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510(k) K202882

Affinity by Hermes Medical Solutions AB — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2020
Date Received
September 28, 2020
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

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  • K193152 — Affinity (February 14, 2020)
  • K191216 — Voxel Dosimetry™ v1.0 (October 17, 2019)
  • K181468 — Hybrid3D (October 25, 2018)
  • K171681 — Hermes Medical Imaging Suite v5.7 (November 21, 2017)
  • K171719 — Hybrid3D (November 21, 2017)
  • K163687 — OLINDA EXM (July 19, 2017)
  • K163394 — Hybrid3D (May 22, 2017)

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  • K252477 — Hybrid Viewer (00859873006240) (September 9, 2025)
  • K250170 — PHAROS (August 15, 2025)
  • K251561 — Biograph Trinion (July 31, 2025)
  • K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (July 17, 2025)
  • K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems (July 3, 2025)