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 | K212067 |
| 510k Number | K212067 |
| 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 | Katelyn Rowley |
| Correspondent | Katelyn Rowley GE Medical Systems, LLC 3000 North Grandview Blvd Waukesha, WI 53188 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-02 |
| Decision Date | 2021-09-17 |