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510(k) K153056

Hermes Medical Imaging Suite v5.6 by Hermes Medical Solutions AB — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2016
Date Received
October 21, 2015
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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  • 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)

Other clearances for product code KPS

  • K253564 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo (February 13, 2026)
  • K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (January 13, 2026)
  • K253844 — AnyScan 3.0 NM Scanner Family (December 30, 2025)
  • K251370 — Cartesion Prime (PCD-1000A/3) V10.21 (December 1, 2025)
  • K251401 — PennPET Explorer Positron Emission Tomograph (November 25, 2025)
  • 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)