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FDA 510(k)

CAPIMAGE

K-Number: K081829 · 2008-07-11

ApplicantDanish Diagnostic Development A/S
Decision Date2008-07-11
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAPIMAGE is the device name listed in this FDA 510(k) record. The listed applicant is Danish Diagnostic Development A/S. It received FDA 510(k) clearance on 2008-07-11 under 510(k) number K081829. 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 CAPIMAGE?

CAPIMAGE is a medical device that received FDA 510(k) clearance on 2008-07-11. The listed applicant is Danish Diagnostic Development A/S. The 510(k) number is K081829.

When did CAPIMAGE receive FDA 510(k) clearance?

CAPIMAGE received FDA 510(k) clearance on 2008-07-11, under 510(k) number K081829.

Who is the listed applicant for CAPIMAGE?

The FDA 510(k) record lists Danish Diagnostic Development A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPIMAGE?

The FDA product code for CAPIMAGE is IYX.

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Other records listing Danish Diagnostic Development A/S 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.

K051460C.CAM-ACK040616CARDIOMD-ACK031825C.CAMK011611CARDIOCAM MODEL 9CSY0799K001888UNICORN MODEL SYS0630

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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