The following data is part of a premarket notification filed by Ever Fortune.ai Co., Ltd. with the FDA for Efai Pacs Picture Archiving And Communication System.
| Device ID | K211257 |
| 510k Number | K211257 |
| Device Name: | EFAI PACS Picture Archiving And Communication System |
| Classification | System, Image Processing, Radiological |
| Applicant | Ever Fortune.AI Co., Ltd. Rm. D, 8F., NO. 573, Sec. 2, Taiwan Blvd., West Dist. Taichung City, TW 403020 |
| Contact | Chen Ming-fong |
| Correspondent | Chen Ming-fong Ever Fortune.AI Co., Ltd. Rm. D, 8F., NO. 573, Sec. 2, Taiwan Blvd., West Dist. Taichung City, TW 403020 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-09-10 |