Sentinella 102; Sentinella 102 Horus

FDA 510(k) K143156 · General Equipment For Medical Imaging (Oncovision-

Substantially Equivalent

510(k) numberK143156

Submission

Device name
Sentinella 102; Sentinella 102 Horus
Applicant
General Equipment For Medical Imaging (Oncovision-
Valencia, ES
Received
November 3, 2014
Decision date
November 18, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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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
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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K162052Sentinella 102, Sentinella 102 HorusIYX · Special 08/18/2016SE
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Questions and answers

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

Sentinella 102; Sentinella 102 Horus (K143156) received a 510(k) decision of Substantially Equivalent on November 18, 2014, 15 days after the submission was received.

What is the product code of K143156?

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