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510(k) K100838

ERGO IMAGING SYSTEM by Digirad Corp. — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2010
Date Received
March 24, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K052430 — CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM (October 4, 2005)
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  • 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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