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

FDA 510(k) K231731 · Mcgovern Medical School

Substantially Equivalent

510(k) numberK231731

Submission

Device name
Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
Applicant
Mcgovern Medical School
Houston, TX, US
Received
June 13, 2023
Decision date
August 21, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPS – System, Tomography, Computed, Emission
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1200
Specialty
Radiology

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More from Hermes Medical Solutions AB

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Questions and answers

When was Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 cleared by the FDA?

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 (K231731) received a 510(k) decision of Substantially Equivalent on August 21, 2023, 69 days after the submission was received.

What is the product code of K231731?

The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.