The following data is part of a premarket notification filed by Cmt Medical Technologies, Ltd. with the FDA for Smartspot 2000.
| Device ID | K991578 |
| 510k Number | K991578 |
| Device Name: | SMARTSPOT 2000 |
| Classification | System, Image Processing, Radiological |
| Applicant | CMT MEDICAL TECHNOLOGIES, LTD. MATAM HIGH TECHNOLOGY CENTER Haifa, IL 31905 |
| Contact | Yeshayahu Raz |
| Correspondent | Yeshayahu Raz CMT MEDICAL TECHNOLOGIES, LTD. MATAM HIGH TECHNOLOGY CENTER Haifa, IL 31905 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-06 |
| Decision Date | 1999-06-03 |