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FDA 510(k)

OLINDA/EXM

K-Number: K033960 · 2004-06-15

ApplicantVanderbilt University
Decision Date2004-06-15
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLINDA/EXM is the device name listed in this FDA 510(k) record. The listed applicant is Vanderbilt University. It received FDA 510(k) clearance on 2004-06-15 under 510(k) number K033960. 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 OLINDA/EXM?

OLINDA/EXM is a medical device that received FDA 510(k) clearance on 2004-06-15. The listed applicant is Vanderbilt University. The 510(k) number is K033960.

When did OLINDA/EXM receive FDA 510(k) clearance?

OLINDA/EXM received FDA 510(k) clearance on 2004-06-15, under 510(k) number K033960.

Who is the listed applicant for OLINDA/EXM?

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

What is the FDA product code for OLINDA/EXM?

The FDA product code for OLINDA/EXM is IYX.

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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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