The following data is part of a premarket notification filed by Cmt Medical Technologies, Ltd. with the FDA for Smart Rad.
| Device ID | K003438 |
| 510k Number | K003438 |
| Device Name: | SMART RAD |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| 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 | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-06 |
| Decision Date | 2001-07-03 |