The following data is part of a premarket notification filed by Ge Medical Systems, L.l.c. with the FDA for Discovery Mi.
| Device ID | K161574 |
| 510k Number | K161574 |
| Device Name: | Discovery MI |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE Medical Systems, L.L.C. 3000 N Grandview Blvd Waukesha, WI 53188 |
| Contact | Helen Peng |
| Correspondent | Helen Peng GE Medical Systems, L.L.C. 3000 N 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 | 2016-06-07 |
| Decision Date | 2016-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682143523 | K161574 | 000 |
| 00840682108218 | K161574 | 000 |
| 00195278098603 | K161574 | 000 |