Cedars-Sinai Cardiac Suite - The Cedars-Sinai Cardiac Suite is a stand-alone - CEDARS-SINAI MEDICAL CENTER

Duns Number:075307785

Device Description: The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PE 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.

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More Product Details

Catalog Number

-

Brand Name

Cedars-Sinai Cardiac Suite

Version/Model Number

2017

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172609

Product Code Details

Product Code

KPS

Product Code Name

System, Tomography, Computed, Emission

Device Record Status

Public Device Record Key

4bd95bbb-4301-40de-bd24-5a4181f43de3

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 09, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CEDARS-SINAI MEDICAL CENTER" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3