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FDA 510(k)

D-SCOPE III

K-Number: K884661 · 1989-04-12

ApplicantMedx, Inc.
Decision Date1989-04-12
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

D-SCOPE III is the device name listed in this FDA 510(k) record. The listed applicant is Medx, Inc.. It received FDA 510(k) clearance on 1989-04-12 under 510(k) number K884661. 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 D-SCOPE III?

D-SCOPE III is a medical device that received FDA 510(k) clearance on 1989-04-12. The listed applicant is Medx, Inc.. The 510(k) number is K884661.

When did D-SCOPE III receive FDA 510(k) clearance?

D-SCOPE III received FDA 510(k) clearance on 1989-04-12, under 510(k) number K884661.

Who is the listed applicant for D-SCOPE III?

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

What is the FDA product code for D-SCOPE III?

The FDA product code for D-SCOPE III is IYX.

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Other records listing Medx, 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.

K082581C-QUESTK073456T-QUEST SYSTEMK041840MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEMK012953GIOTTO IMAGEK993893MEDX INTECAM INTERFACEK872127D-SCOPE II AND D-SCOPE IIC

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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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