FDA 510(k)

Zusätzliche Bildschirmdarstellungen für das von der FDA genehmigte HeartSee Cardiac P.E.T.-Verarbeitungssoftware K143664

K-Nummer: K171303 · 2017-09-22

AntragstellerUniversity of Texas Medical School AT Houston, Texas

Entscheidungsdatum2017-09-22

ProduktcodeKPS

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is the device name listed in this FDA 510(k) record. The listed applicant is University of Texas Medical School AT Houston, Texas. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K171303. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is University of Texas Medical School AT Houston, Texas. The 510(k) number is K171303.

When did Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 receive FDA 510(k) clearance?

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 received FDA 510(k) clearance on 2017-09-22, under 510(k) number K171303.

Who is the listed applicant for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

The FDA 510(k) record lists University of Texas Medical School AT Houston, Texas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

The FDA product code for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is KPS.

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Verwandte Geräte (Code: KPS)

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