The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Deep Learning Image Reconstruction For Gemstone Spectral Imaging.
| Device ID | K201745 |
| 510k Number | K201745 |
| Device Name: | Deep Learning Image Reconstruction For Gemstone Spectral Imaging |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha, WI 53188 |
| Contact | Katelyn Rowley |
| Correspondent | Katelyn Rowley 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 | 2020-06-26 |
| Decision Date | 2020-12-10 |