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FDA 510(k)

GAMMA 600 NUCLEAR MEDICINE COMPUTER

K-Number: K903469 · 1991-02-04

ApplicantStrichman Medical Equipment, Inc.
Decision Date1991-02-04
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GAMMA 600 NUCLEAR MEDICINE COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Strichman Medical Equipment, Inc.. It received FDA 510(k) clearance on 1991-02-04 under 510(k) number K903469. 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 GAMMA 600 NUCLEAR MEDICINE COMPUTER?

GAMMA 600 NUCLEAR MEDICINE COMPUTER is a medical device that received FDA 510(k) clearance on 1991-02-04. The listed applicant is Strichman Medical Equipment, Inc.. The 510(k) number is K903469.

When did GAMMA 600 NUCLEAR MEDICINE COMPUTER receive FDA 510(k) clearance?

GAMMA 600 NUCLEAR MEDICINE COMPUTER received FDA 510(k) clearance on 1991-02-04, under 510(k) number K903469.

Who is the listed applicant for GAMMA 600 NUCLEAR MEDICINE COMPUTER?

The FDA 510(k) record lists Strichman Medical Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA 600 NUCLEAR MEDICINE COMPUTER?

The FDA product code for GAMMA 600 NUCLEAR MEDICINE COMPUTER 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 Strichman Medical Equipment, Inc. 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.

K925186EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSISK923736GAMMA 600T

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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