Home / 510(k) Clearances / K223212

510(k) K223212

Precision DL by Ge Healthcare — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2023
Date Received
October 17, 2022
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 Ge Healthcare

  • K253639 — View (January 8, 2026)
  • K242925 — MR Contour DL (April 1, 2025)
  • K241300 — ViewPoint 6 (July 2, 2024)
  • K232346 — Digital Expert Access with Remote Scanning (October 27, 2023)
  • K221680 — Xeleris V Processing and Review System (March 1, 2023)
  • K221932 — Omni Legend (September 2, 2022)
  • K213689 — Voluson P6, Voluson P8 (February 17, 2022)
  • K213642 — Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert (January 13, 2022)
  • K211488 — LOGIQ E10 (September 10, 2021)
  • K211524 — LOGIQ E10s, LOGIQ Fortis (August 27, 2021)

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)