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FDA 510(k)

ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM

K-Number: K051402 · 2005-06-13

ApplicantGvi Technology Partners
Decision Date2005-06-13
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gvi Technology Partners. It received FDA 510(k) clearance on 2005-06-13 under 510(k) number K051402. 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 ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM?

ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-13. The listed applicant is Gvi Technology Partners. The 510(k) number is K051402.

When did ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM receive FDA 510(k) clearance?

ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM received FDA 510(k) clearance on 2005-06-13, under 510(k) number K051402.

Who is the listed applicant for ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM?

The FDA 510(k) record lists Gvi Technology Partners as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM?

The FDA product code for ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM is IYX.

Related Clinical Trials

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Other records listing Gvi Technology Partners 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.

K072191CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEMK023373ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101

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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