The following data is part of a premarket notification filed by Ge Healthcare Japan Corporation with the FDA for Deep Learning Image Reconstruction.
| Device ID | K220961 |
| 510k Number | K220961 |
| Device Name: | Deep Learning Image Reconstruction |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Healthcare Japan Corporation 7-127, 4-Chome, Asahigaoka Hino, JP 191-8503 |
| Contact | Wang Xing |
| Correspondent | Wang Xing GE Hangwei Medical Systems Co., Ltd. West Area Of Building No.3, No.1 Yongchang North Road Beijing Economic & Technological Develop, CN 100176 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-01 |
| Decision Date | 2022-07-29 |