Home / 510(k) Clearances / K171719

510(k) K171719

Hybrid3D by Hermes Medical Solutions AB — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2017
Date Received
June 9, 2017
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

  • K252477 — Hybrid Viewer (00859873006240) (September 9, 2025)
  • 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)
  • K163687 — OLINDA EXM (July 19, 2017)
  • K163394 — Hybrid3D (May 22, 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)