The following data is part of a premarket notification filed by Radiaction Ltd. with the FDA for Shield System.
| Device ID | K222625 |
| 510k Number | K222625 |
| Device Name: | Shield System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Radiaction Ltd. 10 Hanechoshet St. Tel Aviv, IL 6971072 |
| Contact | Jonathan Yifat |
| Correspondent | Susan Alpert SFADC LLC 2425 L Street NW, Apt 307 Washington, DC 20037 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-31 |
| Decision Date | 2022-09-30 |