The following data is part of a premarket notification filed by Ge Medical Systems, Llc. with the FDA for Maxfov 2.
| Device ID | K203617 |
| 510k Number | K203617 |
| Device Name: | MaxFOV 2 |
| 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 | 2020-12-11 |
| Decision Date | 2021-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278363947 | K203617 | 000 |