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 the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Technologies. It received FDA 510(k) clearance on 2018-01-12 under 510(k) 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. The listed applicant is Cardiovascular Imaging Technologies. The 510(k) number is K173547.

When did ImagenUniversal receive FDA 510(k) clearance?

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

Who is the listed applicant for ImagenUniversal?

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

What is the FDA product code for ImagenUniversal?

The FDA product code for ImagenUniversal is KPS.

Other records listing Cardiovascular Imaging Technologies 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.

K201933ImagenSPECT 3.0 K152503ImagenSPECT

Related Devices (Code: KPS)

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.