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 | K193170 |
| 510k Number | K193170 |
| 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 | Tomohiro Ito |
| Correspondent | Helen Peng GE Medical Systems, LLC 3000 North Grandview Blvd Waukesha, WI 53188 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-15 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146586 | K193170 | 000 |
| 00195278303202 | K193170 | 000 |