The following data is part of a premarket notification filed by Ge Hangwei Medical Systems, Co., Ltd. with the FDA for Revolution Act.
| Device ID | K171013 |
| 510k Number | K171013 |
| Device Name: | Revolution ACT |
| 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 | Wang Xing |
| Correspondent | Wang Xing 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-04 |
| Decision Date | 2017-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146197 | K171013 | 000 |
| 00840682135313 | K171013 | 000 |