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510(k) K070542

CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS by Digirad Corp. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2007
Date Received
February 26, 2007
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)
  • K052430 — CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (October 4, 2005)
  • K051549 — CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (July 13, 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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