Cedars-Sinai Cardiac Suite

GUDID 00864687000209

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 Nuclear medicine system workstation

• Primary Device ID: 00864687000209
• NIH Device Record Key: 012ab79d-7794-4d2e-bcbd-184eaf025d10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cedars-Sinai Cardiac Suite
• Version Model Number: 2015
• Company DUNS: 075307785
• Company Name: CEDARS-SINAI MEDICAL CENTER
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844-276-2246
• Email: support@csaim.com
• Phone: 844-276-2246
• Email: support@csaim.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864687000209 [Previous]
GS1	00864687000223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141652

FDA Product Code

• KPS: System, Tomography, Computed, Emission

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-18

On-Brand Devices [Cedars-Sinai Cardiac Suite]

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