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FDA 510(k)

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

K-Number: K202679 · 2021-04-12

ApplicantMcgovern Medical School
Decision Date2021-04-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 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 2021-04-12 under 510(k) number K202679. 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 Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Mcgovern Medical School. The 510(k) number is K202679.

When did Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 receive FDA 510(k) clearance?

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 received FDA 510(k) clearance on 2021-04-12, under 510(k) number K202679.

Who is the listed applicant for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

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

The FDA product code for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is KPS.

Related Clinical Trials

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.

NCT06034392CHAMP App Cardiac Study and RepositoryENROLLING_BY_INVITATION

Other records listing Mcgovern Medical School 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.

K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

Related Devices (Code: KPS)

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.

K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilySiemens Medical Solutions USA, Inc.K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd.K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd.

Official Source

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