Home / 510(k) Clearances / K040616

510(k) K040616

CARDIOMD-AC by Danish Diagnostic Development A/S — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2004
Date Received
March 9, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Danish Diagnostic Development A/S

  • K081829 — CAPIMAGE (July 11, 2008)
  • K051460 — C.CAM-AC (June 15, 2005)
  • K031825 — C.CAM (June 20, 2003)
  • K011611 — CARDIOCAM MODEL 9CSY0799 (June 8, 2001)
  • K001888 — UNICORN MODEL SYS0630 (June 30, 2000)

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)