Revolution Ascend
FDA 510(k) clearance K213938 · decided 2022-02-04
Clearance details
- K-number
- K213938
- Device name
- Revolution Ascend
- Applicant
- Ge Healthcare Japan Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-12-16
- Decision date
- 2022-02-04
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hino, JP
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ge Healthcare Japan Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BodyTom Elite (NL4000) (K253450) | NeuroLogica Corp., a Samsung Company | 2026-07-28 |
| CardIQ Suite (K253770) | GE Medical Systems SCS | 2026-07-21 |
| Enhanced Boundary for PCCT (K253560) | Ge Medical Systems, LLC | 2026-06-24 |
| Respiratory Gating for Scanners (2.1) (K253026) | Varian Medical Systems, Inc. | 2026-06-04 |
| Aquilion ONE (TSX-308A/TSX-306A) V2.0 (K253596) | Canon Medical Systems Corporation | 2026-05-20 |
| Spectral CT Verida Family (K253649) | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
| True Definition DL (K253686) | Ge Healthcare Japan Corporation | 2026-03-23 |
| CT Rembra RT; CT Areta RT; CT Rembra (K252992) | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| Photonova Spectra, Photonova Spectra Select (K253520) | Ge Medical Systems, LLC | 2026-03-20 |
| SOMATOM X.cite; SOMATOM X.ceed (K253574) | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| Aquilion ServeSP (TSX-307B) V2.0 (K260078) | Canon Medical Systems Corporation | 2026-03-13 |
| Extremity CT Imaging System (K252249) | Mars Bioimaging , Ltd. | 2026-03-13 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 recall (Z-2149-2026) | GE Medical Systems, LLC | 2026-05-08 |
| GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography syste recall (Z-0605-2025) | GE Healthcare (China) Co., Ltd. | 2024-12-04 |