Cedars-Sinai Cardiac Suite

GUDID 00864687000247

The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.

CEDARS-SINAI MEDICAL CENTER

Nuclear medicine system workstation
Primary Device ID00864687000247
NIH Device Record Key4bd95bbb-4301-40de-bd24-5a4181f43de3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCedars-Sinai Cardiac Suite
Version Model Number2017
Company DUNS075307785
Company NameCEDARS-SINAI MEDICAL CENTER
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com
Phone844-276-2246
Emailsupport@csaim.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100864687000247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPSSystem, Tomography, Computed, Emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-10
Device Publish Date2018-08-09

On-Brand Devices [Cedars-Sinai Cardiac Suite]

00864687000247The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imag
00864687000209The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imag
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