The following data is part of a premarket notification filed by Shai Syg Motion And Innovations, Ltd. with the FDA for The Roboguide.
| Device ID | K961849 |
| 510k Number | K961849 |
| Device Name: | THE ROBOGUIDE |
| Classification | System, X-ray, Mammographic |
| Applicant | SHAI SYG MOTION AND INNOVATIONS, LTD. POB 6718 EFRAT, IL 90435 |
| Contact | ELI M ORBACH |
| Correspondent | ELI M ORBACH SHAI SYG MOTION AND INNOVATIONS, LTD. POB 6718 EFRAT, IL 90435 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-13 |
| Decision Date | 1996-08-21 |