Home / 510(k) Clearances / K982171

510(k) K982171

HAMAMATSU PET SCANNER, MODEL SHR-22000 by Hamamatsu Photonics K.K. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1998
Date Received
June 19, 1998
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 Hamamatsu Photonics K.K.

  • K233027 — NanoZoomer S360MD Slide scanner system (December 22, 2023)
  • K213883 — NanoZoomer S360MD Slide scanner system (September 27, 2022)
  • K162117 — NIRO-200NX DP (October 25, 2016)
  • K143219 — NIRO-200NX (July 31, 2015)
  • K133719 — PDE-NEO (March 27, 2014)
  • K110480 — PDE PHOTODYNAMIC EYE (January 13, 2012)
  • K896331 — V2465P X-RAY IMAGE INTENSIFIER (December 22, 1989)

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)