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510(k) K143156

Sentinella 102; Sentinella 102 Horus by General Equipment For Medical Imaging (Oncovision- — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2014
Date Received
November 3, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by General Equipment For Medical Imaging (Oncovision-

  • K162052 — Sentinella 102, Sentinella 102 Horus (August 18, 2016)
  • K140996 — MAMMI (June 11, 2014)

Other clearances for product code IYX

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  • K212587 — 3D-RD-S (February 22, 2023)
  • K163687 — OLINDA EXM (July 19, 2017)
  • K160933 — Discovery NM 750b Bopsy (November 18, 2016)
  • K162052 — Sentinella 102, Sentinella 102 Horus (August 18, 2016)
  • K123408 — ERGO IMAGING SYSTEM (January 15, 2013)
  • K111791 — LUMAGEM MOLECULAR BREAST IMAGING SYSTEM (September 23, 2011)
  • K110384 — DILON 6800 ACELLA (ACELLA) (May 3, 2011)
  • K110601 — SENTINELLA 102 (March 18, 2011)
  • K102231 — DISCOVERY NM 750B (November 3, 2010)