Home / 510(k) Clearances / K211846

510(k) K211846

Discovery MI Gen2 by Ge Medical Systems, LLC — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2021
Date Received
June 15, 2021
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 Medical Systems, LLC

  • K253780 — SIGNA™ Bolt (February 6, 2026)
  • K253779 — SIGNA™ Sprint Select (February 5, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
  • K251399 — SIGNA™ Sprint (September 11, 2025)
  • K250941 — Revolution Vibe (August 1, 2025)
  • K243667 — Sonic DL (June 5, 2025)
  • K250379 — SIGNA Prime Elite (March 17, 2025)
  • K241242 — SIGNA MAGNUS (October 17, 2024)
  • K233750 — ECG-less Cardiac (April 2, 2024)
  • K223491 — Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suit (May 25, 2023)

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)