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510(k) K162052

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2016
Date Received
July 25, 2016
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

Other clearances by General Equipment For Medical Imaging (Oncovision-

  • K143156 — Sentinella 102; Sentinella 102 Horus (November 18, 2014)
  • K140996 — MAMMI (June 11, 2014)

Other clearances for product code IYX

  • K230221 — QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiot (August 28, 2023)
  • K212587 — 3D-RD-S (February 22, 2023)
  • K163687 — OLINDA EXM (July 19, 2017)
  • K160933 — Discovery NM 750b Bopsy (November 18, 2016)
  • K143156 — Sentinella 102; Sentinella 102 Horus (November 18, 2014)
  • 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)