The following data is part of a premarket notification filed by Ever Fortune.ai Co., Ltd. with the FDA for Efai Chestsuite Xr Pleural Effusion Assessment System.
| Device ID | K222076 |
| 510k Number | K222076 |
| Device Name: | EFAI ChestSuite XR Pleural Effusion Assessment System |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | Ever Fortune.AI Co., Ltd. RM. D, 8 F., 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, 8 F., NO. 573, SEC. 2, TAIWAN BLVD., WEST DIST. Taichung City, TW 403020 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-14 |
| Decision Date | 2022-09-08 |