Revolution Ascend— 510(k) K213938
Substantially EquivalentGe Healthcare Japan Corporation
FDA 510(k) clearance K213938 for Revolution Ascend, Substantially Equivalent on 2022-02-04. Applicant: Ge Healthcare Japan Corporation. Device class: 2.
Clearance details
- Applicant
- Ge Healthcare Japan Corporation
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hino, JP
Recent devices under product code JAK
view allMore clearances from Ge Healthcare Japan Corporation
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K213938
K-number listed on FDA's recall record- Z-2149-2026 — Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
- Z-0605-2025 — GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213938.
Data sourced from openFDA. This site is unofficial and independent of the FDA.