Home / 510(k) Clearances / K051549

510(k) K051549

CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM by Digirad Corp. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2005
Date Received
June 13, 2005
Clearance Type
Special
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 Digirad Corp.

  • K123408 — ERGO IMAGING SYSTEM (January 15, 2013)
  • K100838 — ERGO IMAGING SYSTEM (April 23, 2010)
  • K083649 — CARDIUS 3 X-ACT (March 9, 2009)
  • K082904 — STASYS MOTION CORRECTION SOFTWARE (December 17, 2008)
  • K082368 — CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMA (September 12, 2008)
  • K070542 — CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS (March 23, 2007)
  • K052430 — CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (October 4, 2005)
  • K030085 — CARDIUS-1 AND CARDIS-2 (February 5, 2003)
  • K023110 — CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 (November 22, 2002)
  • K011572 — QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) (June 15, 2001)

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