Data / Medical devices / Israel / Shina Systems Ltd.
Shina Systems Ltd.: FDA-registered device maker in CAESAREA, 3079504 Haifa, Israel, 3 510(k) clearances
Shina Systems Ltd. is registered with the FDA (registration 3006551230) in CAESAREA, 3079504 Haifa, Israel. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 16, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006551230
- Address
- 7 Haeshel ST. P.O.Box 3072, CAESAREA INDUSTRIAL PARK SOUTH, CAESAREA, 3079504 Haifa, Israel, 3079504
- Owner or operator
- SHINA SYSTEMS LTD. (9097024)
- Roles
- Manufacturer
- First device listed
- October 23, 2011
- Registered through
- 2026
- Brand names listed
- 3DI INCLUDING CSCORE, 3Di, 3Di including Viewing of Mammography images
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 16, 2012 | K113442 | 3DI | LLZ | Substantially Equivalent | Shina Systems , Ltd. | accessdata.fda.gov |
| September 30, 2011 | K112530 | 3DI INCLUDING CSCORE | LLZ | Substantially Equivalent | Shina Systems , Ltd. | accessdata.fda.gov |
| January 19, 2010 | K093703 | 3DI | LLZ | Substantially Equivalent | Shina Systems , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 16, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.