Sentinella 102, Sentinella 102 Horus

FDA 510(k) K162052 · General Equipment For Medical Imaging (Oncovision-

Substantially Equivalent

510(k) numberK162052

Submission

Device name
Sentinella 102, Sentinella 102 Horus
Applicant
General Equipment For Medical Imaging (Oncovision-
Valencia, ES
Received
July 25, 2016
Decision date
August 18, 2016
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

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

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K163687Olinda ExmIYX · Traditional Hermes Medical Solutions AB07/19/2017SE
K160933Discovery NM 750b BopsyIYX · Traditional GE Healthcare11/18/2016SE
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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
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K102231Discovery NM 750BIYX · Traditional Ge Medical Systems Israel, Functional Imaging11/03/2010SE

More from Ge Medical Systems Israel, Functional Imaging

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K143156Sentinella 102; Sentinella 102 HorusIYX · Traditional 11/18/2014SE
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Questions and answers

When was Sentinella 102, Sentinella 102 Horus cleared by the FDA?

Sentinella 102, Sentinella 102 Horus (K162052) received a 510(k) decision of Substantially Equivalent on August 18, 2016, 24 days after the submission was received.

What is the product code of K162052?

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