The following data is part of a premarket notification filed by Shina Systems Ltd. with the FDA for 3di Including Cscore.
| Device ID | K112530 |
| 510k Number | K112530 |
| Device Name: | 3DI INCLUDING CSCORE |
| Classification | System, Image Processing, Radiological |
| Applicant | SHINA SYSTEMS LTD. 6 SIRENI Haifa, IL 32972 |
| Contact | Dan Laor |
| Correspondent | Dan Laor SHINA SYSTEMS LTD. 6 SIRENI Haifa, IL 32972 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-31 |
| Decision Date | 2011-09-30 |
| Summary: | summary |