Model Sentinella 102

FDA 510(k) K092471 · General Equipment For Medical Imaging, S.A.

Substantially Equivalent

510(k) numberK092471

Submission

Device name
Model Sentinella 102
Applicant
General Equipment For Medical Imaging, S.A.
Valencia, ES
Received
August 11, 2009
Decision date
October 2, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
IYX – Camera, Scintillation (Gamma)
Device class
Class I (low risk)
Regulation
21 CFR 892.1100
Specialty
Radiology

Other 510(k)s with product code IYX

510(k)DeviceApplicantDecision
K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)IYX · Traditional Versant Medical Physics and Radiation Safety08/28/2023SE
K2125873D-RD-SIYX · Traditional Radiopharmaceutical Imaging and Dosimetry, LLC02/22/2023SE
K163687Olinda ExmIYX · Traditional Hermes Medical Solutions AB07/19/2017SE
K160933Discovery NM 750b BopsyIYX · Traditional GE Healthcare11/18/2016SE
K162052Sentinella 102, Sentinella 102 HorusIYX · Special General Equipment For Medical Imaging (Oncovision-08/18/2016SE
K143156Sentinella 102; Sentinella 102 HorusIYX · Traditional General Equipment For Medical Imaging (Oncovision-11/18/2014SE
K123408Ergo Imaging SystemIYX · Traditional Digirad Corp.01/15/2013SE
K111791Lumagem Molecular Breast Imaging SystemIYX · Traditional Gamma Medica-Ideas Incorporated09/23/2011SE
K110384Dilon 6800 Acella (Acella)IYX · Traditional Dilon Technologies, Inc.05/03/2011SE
K110601Sentinella 102IYX · Traditional General Equipment For Medical Imaging, S.A.03/18/2011SE

More from General Equipment For Medical Imaging, S.A.

510(k)DeviceDecision
K232569CaremibrainKPS · Traditional 09/21/2023SE
K110601Sentinella 102IYX · Traditional 03/18/2011SE

Questions and answers

When was Model Sentinella 102 cleared by the FDA?

Model Sentinella 102 (K092471) received a 510(k) decision of Substantially Equivalent on October 2, 2009, 52 days after the submission was received.

What is the product code of K092471?

The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.