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Sign in to claim this brandCedars-Sinai Medical Center
United States·US-MF-000011960
Last updated May 30, 2026
What Cedars-Sinai Medical Center makes
The manufacturer produces image segmentation software tailored for cardiac imaging, including specialized applications for nuclear medicine. These tools are designed to analyze and interpret cardiac scans, supporting diagnostic and treatment planning workflows in clinical settings.
The portfolio includes devices classified as Class II and Class IIa under regulatory frameworks, with listings in the EUDAMED database, FDA’s 510(k) premarket notifications, and FDA’s Unique Device Identification (UDI) system. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Cedars-Sinai Medical Center manufacture?
Cedars-Sinai Medical Center develops image segmentation application software, specifically tailored for cardiac imaging. These tools focus on analyzing and interpreting cardiac scans, including specialized applications for nuclear medicine. The software supports diagnostic and treatment planning workflows in clinical environments.
Where is Cedars-Sinai Medical Center based?
Cedars-Sinai Medical Center is based in the United States. While it operates as a healthcare institution, its medical device software portfolio is designed and developed there.
Which regulatory registries list Cedars-Sinai Medical Center’s devices?
Cedars-Sinai Medical Center’s devices are listed in the EUDAMED database for European regulatory transparency, as well as in the FDA’s 510(k) premarket notifications and the FDA’s Unique Device Identification (UDI) system. These registries help track and monitor the devices’ regulatory status globally.
How are Cedars-Sinai Medical Center’s devices classified under regulatory frameworks?
The devices produced by Cedars-Sinai Medical Center fall under Class II and Class IIa classifications. These classifications are determined by regulatory authorities based on factors like the device’s intended use, risk level, and potential impact on patient safety, with Class IIa representing a lower risk than Class II.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 6500, Wilshire Blvd, Los Angeles, United States
- Website
- www.csaim.com
- —
- —
- [email protected]
- Phone
- +1 844-276-2246
- PRRC Contact
- Aarti Bhardwaj
- EUDAMED SRN
- US-MF-000011960
- FDA FEI Number
- —
- DUNS Number
- 075307785
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cedars-Sinai Cardiac Suite | 2015 | FDA UDI | Class II | Active |
| Cedars-Sinai Cardiac Suite | 2015 | FDA UDI | Class II | Active |
| Dexter Hand Evaluation And Therapy System | K915144 | FDA 510(k) | Class II | Active |
| Csmc Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01 | K100714 | FDA 510(k) | Class II | Active |
| Cedars-Sinai Cardiac Suite Nuclear Medicine Software | K123433 | FDA 510(k) | Class II | Active |
| Autoplaque | K212758 | FDA 510(k) | Class II | Active |
| Cedars-Sinai Cardiac Suite Nuclear Medicine Software | K141652 | FDA 510(k) | Class II | Active |
| Csmc Cardiac Suite- Nuclear Medicine Software | K112474 | FDA 510(k) | Class II | Active |
| CSMC Cardiac Suite | CSMC Cardiac Suite V2017 | EUDAMEDFDA UDI | Class IIa | Active |
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