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510(k) K252477

Hybrid Viewer (00859873006240) by Hermes Medical Solutions AB — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2025
Date Received
August 7, 2025
Clearance Type
Special
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

  • K243919 — Voxel Dosimetry (00859873006226) (July 30, 2025)
  • K241364 — Hybrid Viewer (00859873006189) (November 8, 2024)
  • K202882 — Affinity (December 23, 2020)
  • 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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  • 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)
  • K251153 — Aurora (June 12, 2025)