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CSMC Cardiac Suite
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref CSMC Cardiac Suite V2017
Identity
- Trade Name
- CSMC Cardiac Suite EUDAMEDCedars-Sinai Cardiac Suite FDA UDI
- Generic Name
- Image segmentation application software FDA UDI
- Device Name
- Cedars-Sinai Cardiac Suite EUDAMEDThe 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. FDA UDI
- Model / Reference
- CSMC Cardiac Suite V2017 EUDAMED2017 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864687000247 EUDAMEDFDA UDI
- Basic UDI-DI
- 08646870002473P EUDAMED
- 510(k) Number
- K172609 FDA UDI
- FDA Product Code
- KPS FDA UDI
- EMDN Code
- Z11029092 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Image segmentation application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CSMC Cardiac Suite by Cedars-Sinai Medical Center — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172609 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08646870002473P | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cedars-Sinai Medical Center
- EUDAMED SRN
- US-MF-000011960
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (3)
- EUDAMED 6ec0ad6f-5c7f-4ffa-be97-ea4f2d7da08d 61 fields · synced Jul 24, 2026
- FDA UDI 4bd95bbb-4301-40de-bd24-5a4181f43de3 35 fields · synced May 30, 2026
- FDA 510(k) K172609 1 fields · synced May 18, 2026