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510(k) K081829

CAPIMAGE by Danish Diagnostic Development A/S — Product Code IYX

K081829 is an FDA 510(k) premarket notification submitted by Danish Diagnostic Development A/S for the device "CAPIMAGE". The FDA issued a decision of Substantially Equivalent on July 11, 2008. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Danish Diagnostic Development A/S has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2008
Date Received
June 27, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

Other clearances by Danish Diagnostic Development A/S

  • K051460 — C.CAM-AC (June 15, 2005)
  • K040616 — CARDIOMD-AC (March 24, 2004)
  • 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 IYX

  • K230221 — QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiot (August 28, 2023)
  • K212587 — 3D-RD-S (February 22, 2023)
  • K163687 — OLINDA EXM (July 19, 2017)
  • K160933 — Discovery NM 750b Bopsy (November 18, 2016)
  • K162052 — Sentinella 102, Sentinella 102 Horus (August 18, 2016)
  • K143156 — Sentinella 102; Sentinella 102 Horus (November 18, 2014)
  • K123408 — ERGO IMAGING SYSTEM (January 15, 2013)
  • K111791 — LUMAGEM MOLECULAR BREAST IMAGING SYSTEM (September 23, 2011)
  • K110384 — DILON 6800 ACELLA (ACELLA) (May 3, 2011)
  • K110601 — SENTINELLA 102 (March 18, 2011)

FDA data resources