The following data is part of a premarket notification filed by Livermoretech Inc. with the FDA for Flusion-9001, Fluoroscopic C-arm Mobile X-ray System.
| Device ID | K200022 |
| 510k Number | K200022 |
| Device Name: | FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | LiverMoreTech Inc. 801 North Jupiter Rd, Suite 200 Plano, TX 75074 |
| Contact | Jae Hong Kim |
| Correspondent | Dave Kim MTech Group 7707 Fannin St. Ste 200 Houston, TX 77054 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-06 |
| Decision Date | 2020-04-03 |