The following data is part of a premarket notification filed by Radiaction Ltd. with the FDA for Shield System.
| Device ID | K212159 |
| 510k Number | K212159 |
| Device Name: | Shield System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Radiaction Ltd. 10 Hanechoshet St. Tel Aviv, IL 69710 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2022-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018378045 | K212159 | 000 |