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FDA 510(k)

VISION FX 40 & 80 SERIES GAMMA CAMERA

K-Number: K935273 · 1994-04-18

ApplicantSummit Nuclear
Decision Date1994-04-18
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISION FX 40 & 80 SERIES GAMMA CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Summit Nuclear. It received FDA 510(k) clearance on 1994-04-18 under 510(k) number K935273. 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 VISION FX 40 & 80 SERIES GAMMA CAMERA?

VISION FX 40 & 80 SERIES GAMMA CAMERA is a medical device that received FDA 510(k) clearance on 1994-04-18. The listed applicant is Summit Nuclear. The 510(k) number is K935273.

When did VISION FX 40 & 80 SERIES GAMMA CAMERA receive FDA 510(k) clearance?

VISION FX 40 & 80 SERIES GAMMA CAMERA received FDA 510(k) clearance on 1994-04-18, under 510(k) number K935273.

Who is the listed applicant for VISION FX 40 & 80 SERIES GAMMA CAMERA?

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

What is the FDA product code for VISION FX 40 & 80 SERIES GAMMA CAMERA?

The FDA product code for VISION FX 40 & 80 SERIES GAMMA CAMERA is IYX.

Related Clinical Trials

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.

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Other records listing Summit Nuclear 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.

K935318SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMSK922427SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEMK922426SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEMK920958SUMMIT NUCLEAR VISION NEUROSPECTK912573VISION (NUCLEAR MEDICINE COMPUTER)

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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