The following data is part of a premarket notification filed by Ever Fortune.ai Co., Ltd. with the FDA for Efai Rtsuite Ct Hn-segmentation System.
| Device ID | K220264 |
| 510k Number | K220264 |
| Device Name: | EFAI RTSuite CT HN-Segmentation System |
| Classification | Radiological Image Processing Software For Radiation Therapy |
| Applicant | Ever Fortune.AI Co., Ltd. Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd., West Dist. Taichung City, TW 403020 |
| Contact | Joseph Chang |
| Correspondent | Ti-hao Wang Ever Fortune.AI Co., Ltd. Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd., West Dist. Taichung City, TW 403020 |
| Product Code | QKB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-04-28 |