The following data is part of a premarket notification filed by Ge Hangwei Medical Systems Co.,ltd. with the FDA for Revolution Maxima, Revolution Ace.
| Device ID | K192686 |
| 510k Number | K192686 |
| Device Name: | Revolution Maxima, Revolution Ace |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Hangwei Medical Systems Co.,Ltd. West Area Of Building No.3, No.1 Yongchang North Road Beijing Economic And Technological Devel, CN 100176 |
| Contact | Haibo He |
| Correspondent | Haibo He GE Hangwei Medical Systems Co.,Ltd. West Area Of Building No.3, No.1 Yongchang North Road Beijing Economic And Technological Devel, CN 100176 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2019-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146937 | K192686 | 000 |
| 00840682146180 | K192686 | 000 |
| 00840682146159 | K192686 | 000 |
| 00840682147392 | K192686 | 000 |
| 00195278686718 | K192686 | 000 |