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FDA 510(k)

CSMC Cardiac Suite

K-Number: K172609 · 2017-11-03

ApplicantCedars-Sinai Medical Center
Decision Date2017-11-03
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CSMC Cardiac Suite is the device name listed in this FDA 510(k) record. The listed applicant is Cedars-Sinai Medical Center. It received FDA 510(k) clearance on 2017-11-03 under 510(k) number K172609. 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 CSMC Cardiac Suite?

CSMC Cardiac Suite is a medical device that received FDA 510(k) clearance on 2017-11-03. The listed applicant is Cedars-Sinai Medical Center. The 510(k) number is K172609.

When did CSMC Cardiac Suite receive FDA 510(k) clearance?

CSMC Cardiac Suite received FDA 510(k) clearance on 2017-11-03, under 510(k) number K172609.

Who is the listed applicant for CSMC Cardiac Suite?

The FDA 510(k) record lists Cedars-Sinai Medical Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CSMC Cardiac Suite?

The FDA product code for CSMC Cardiac Suite is KPS.

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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.

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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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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