FDA 510(k)

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

K-Nummer: K231731 · 2023-08-21

Entscheidungsdatum2023-08-21

ProduktcodeKPS

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is the device name listed in this FDA 510(k) record. The listed applicant is Mcgovern Medical School. It received FDA 510(k) clearance on 2023-08-21 under 510(k) number K231731. 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 Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is a medical device that received FDA 510(k) clearance on 2023-08-21. The listed applicant is Mcgovern Medical School. The 510(k) number is K231731.

When did Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 receive FDA 510(k) clearance?

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 received FDA 510(k) clearance on 2023-08-21, under 510(k) number K231731.

Who is the listed applicant for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

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

What is the FDA product code for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

The FDA product code for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is KPS.

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Weitere Einträge mit Mcgovern Medical School als Antragsteller

K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

Verwandte Geräte (Code: KPS)

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