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510(k) K111791

LUMAGEM MOLECULAR BREAST IMAGING SYSTEM by Gamma Medica-Ideas Incorporated — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2011
Date Received
June 27, 2011
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

Other clearances by Gamma Medica-Ideas Incorporated

  • K111731 — MOLECULAR BREAST IMAGING SOFTWARE (September 15, 2011)

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  • K123408 — ERGO IMAGING SYSTEM (January 15, 2013)
  • K110384 — DILON 6800 ACELLA (ACELLA) (May 3, 2011)
  • K110601 — SENTINELLA 102 (March 18, 2011)
  • K102231 — DISCOVERY NM 750B (November 3, 2010)