Is this your brand? Sign in to claim ownership.
Sign in to claim this brandShina Systems , Ltd.
US
Last updated May 31, 2026
What Shina Systems , Ltd. makes
Shina Systems, Ltd. develops radiological Picture Archiving and Communication Systems (PACS) software, including specialized tools for cardiac imaging and quantitative analysis. Their portfolio includes 3Di, a platform for volumetric and functional cardiac assessment, and CardioCT, designed for analyzing computed tomography scans of the heart. These solutions integrate image processing, automated measurements, and reporting features for diagnostic workflows.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. Their products are regulated as software-as-a-medical-device (SaMD) under the U.S. jurisdiction. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 514770445
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 3Di | 3.2 | FDA UDI | Class II | Active |
| 3di Including Cscore | K112530 | FDA 510(k) | Class II | Active |
| 3di | K093703 | FDA 510(k) | Class II | Active |
| Cardioct | K070226 | FDA 510(k) | Class II | Active |
| 3di | K113442 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Shina Systems Ltd. CAESAREA, 3079504 Haifa · IL FEI 3006551230