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FDA 510(k)

MODEL SENTINELLA 102

K-Number: K092471 · 2009-10-02

ApplicantGeneral Equipment For Medical Imaging, S.A.
Decision Date2009-10-02
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL SENTINELLA 102 is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging, S.A.. It received FDA 510(k) clearance on 2009-10-02 under 510(k) number K092471. 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 MODEL SENTINELLA 102?

MODEL SENTINELLA 102 is a medical device that received FDA 510(k) clearance on 2009-10-02. The listed applicant is General Equipment For Medical Imaging, S.A.. The 510(k) number is K092471.

When did MODEL SENTINELLA 102 receive FDA 510(k) clearance?

MODEL SENTINELLA 102 received FDA 510(k) clearance on 2009-10-02, under 510(k) number K092471.

Who is the listed applicant for MODEL SENTINELLA 102?

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

What is the FDA product code for MODEL SENTINELLA 102?

The FDA product code for MODEL SENTINELLA 102 is IYX.

Related Clinical Trials

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Other records listing General Equipment For Medical Imaging, S.A. as applicant

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.

K232569CAREMIBRAINK110601SENTINELLA 102

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 HealthcareK162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-K123408ERGO IMAGING SYSTEMDigirad Corp.

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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