Home / 510(k) Clearances / K110601

510(k) K110601

SENTINELLA 102 by General Equipment For Medical Imaging, S.A. — Product Code IYX

K110601 is an FDA 510(k) premarket notification submitted by General Equipment For Medical Imaging, S.A. for the device "SENTINELLA 102". The FDA issued a decision of Substantially Equivalent on March 18, 2011. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. General Equipment For Medical Imaging, S.A. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2011
Date Received
March 2, 2011
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, S.A.

  • K232569 — CAREMIBRAIN (September 21, 2023)
  • K161631 — MAMMI (July 28, 2016)
  • K092471 — MODEL SENTINELLA 102 (October 2, 2009)

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)
  • K162052 — Sentinella 102, Sentinella 102 Horus (August 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)
  • K102231 — DISCOVERY NM 750B (November 3, 2010)

FDA data resources