The following data is part of a premarket notification filed by Ge Medical Systems, Llc. with the FDA for Discovery Mi Gen2.
| Device ID | K211846 |
| 510k Number | K211846 |
| Device Name: | Discovery MI Gen2 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE Medical Systems, LLC. 3000 North Grandview Blvd Waukesha, WI 53188 |
| Contact | Laura Turner |
| Correspondent | Laura Turner GE Medical Systems, LLC. 3000 North Grandview Blvd Waukesha, WI 53188 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-15 |
| Decision Date | 2021-08-20 |