The following data is part of a premarket notification filed by Ge Healthcare Japan Corporation with the FDA for Revolution Ascend.
| Device ID | K213938 |
| 510k Number | K213938 |
| Device Name: | Revolution Ascend |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE Healthcare Japan Corporation 7-127, 4-Chome, Asahigaoka, Hino, JP 191-8503 |
| Contact | He Haibo |
| Correspondent | He Haibo GE Healthcare Japan Corporation 7-127, 4-Chome, Asahigaoka, Hino, JP 191-8503 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-16 |
| Decision Date | 2022-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278718204 | K213938 | 000 |
| 00195278718136 | K213938 | 000 |
| 00195278718129 | K213938 | 000 |