The following data is part of a premarket notification filed by Ge Medical Systems, Llc. with the FDA for Deep Learning Image Reconstruction.
| Device ID | K213999 |
| 510k Number | K213999 |
| Device Name: | Deep Learning Image Reconstruction |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Medical Systems, LLC. 3000 N. Grandview Blvd. Waukesha, WI 53188 |
| Contact | Amy Yang |
| Correspondent | Amy Yang GE Medical Systems, LLC. 3000 N. 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 | 2021-12-21 |
| Decision Date | 2022-02-18 |