The following data is part of a premarket notification filed by Shina Systems Ltd. with the FDA for Cardioct.
| Device ID | K070226 |
| 510k Number | K070226 |
| Device Name: | CARDIOCT |
| Classification | System, Image Processing, Radiological |
| Applicant | SHINA SYSTEMS LTD. POB 6718 Efrat, IL 90435 |
| Contact | Eli M Orbach |
| Correspondent | Eli M Orbach SHINA SYSTEMS LTD. POB 6718 Efrat, IL 90435 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-24 |
| Decision Date | 2007-03-09 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CARDIOCT 78254121 not registered Dead/Abandoned |
Shina syatem LTD 2003-05-24 |