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510(k) K031825

C.CAM by Danish Diagnostic Development A/S — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2003
Date Received
June 13, 2003
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)
  • K040616 — CARDIOMD-AC (March 24, 2004)
  • K011611 — CARDIOCAM MODEL 9CSY0799 (June 8, 2001)
  • K001888 — UNICORN MODEL SYS0630 (June 30, 2000)

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  • K253844 — AnyScan 3.0 NM Scanner Family (December 30, 2025)
  • K251370 — Cartesion Prime (PCD-1000A/3) V10.21 (December 1, 2025)
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  • 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)