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510(k) K123408

ERGO IMAGING SYSTEM by Digirad Corp. — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2013
Date Received
November 5, 2012
Clearance Type
Traditional
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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  • 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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