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FDA 510(k)

Sentinella 102, Sentinella 102 Horus

K-Number: K162052 · 2016-08-18

ApplicantGeneral Equipment For Medical Imaging (Oncovision-
Decision Date2016-08-18
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sentinella 102, Sentinella 102 Horus is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging (Oncovision-. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K162052. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sentinella 102, Sentinella 102 Horus?

Sentinella 102, Sentinella 102 Horus is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is General Equipment For Medical Imaging (Oncovision-. The 510(k) number is K162052.

When did Sentinella 102, Sentinella 102 Horus receive FDA 510(k) clearance?

Sentinella 102, Sentinella 102 Horus received FDA 510(k) clearance on 2016-08-18, under 510(k) number K162052.

Who is the listed applicant for Sentinella 102, Sentinella 102 Horus?

The FDA 510(k) record lists General Equipment For Medical Imaging (Oncovision- as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sentinella 102, Sentinella 102 Horus?

The FDA product code for Sentinella 102, Sentinella 102 Horus is IYX.

Related Devices (Code: IYX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXMHermes Medical Solutions ABK160933Discovery NM 750b BopsyGE Healthcare

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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