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FDA 510(k)

ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101

K-Number: K023373 · 2003-01-03

ApplicantGvi Technology Partners
Decision Date2003-01-03
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 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 2003-01-03 under 510(k) number K023373. 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 IMAGING SYSTEM, MODEL 70-500101?

ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 is a medical device that received FDA 510(k) clearance on 2003-01-03. The listed applicant is Gvi Technology Partners. The 510(k) number is K023373.

When did ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 receive FDA 510(k) clearance?

ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 received FDA 510(k) clearance on 2003-01-03, under 510(k) number K023373.

Who is the listed applicant for ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101?

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 IMAGING SYSTEM, MODEL 70-500101?

The FDA product code for ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 is IYX.

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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 SYSTEMK051402ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM

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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