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FDA 510(k)

ImagenUniversal

K-Number: K173547 · 2018-01-12

ApplicantCardiovascular Imaging Technologies
Decision Date2018-01-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ImagenUniversal is a medical device manufactured by Cardiovascular Imaging Technologies. It received FDA 510(k) clearance on 2018-01-12 under approval number K173547. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImagenUniversal?

ImagenUniversal is a medical device that received FDA 510(k) clearance on 2018-01-12. It is manufactured by Cardiovascular Imaging Technologies. The 510(k) number is K173547.

When was ImagenUniversal approved by the FDA?

ImagenUniversal received FDA 510(k) clearance on 2018-01-12, under approval number K173547.

What company makes ImagenUniversal?

ImagenUniversal is manufactured by Cardiovascular Imaging Technologies.

What is the FDA product code for ImagenUniversal?

The FDA product code for ImagenUniversal is KPS.

Other Devices by Cardiovascular Imaging Technologies

K152503ImagenSPECT K201933ImagenSPECT 3.0

Related Devices (Code: KPS)

K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc. K161674QuantumCamDdd-Diagnostic A/S K162337Symbia 6.5Siemens Medical Solutions USA, Inc. K161574Discovery MIGe Medical Systems, LLC K161631MAMMIGeneral Equipment For Medical Imaging

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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