Revolution Maxima, Revolution Ace— 510(k) K192686
Substantially EquivalentGe Hangwei Medical Systems Co., Ltd.
FDA 510(k) clearance K192686 for Revolution Maxima, Revolution Ace, Substantially Equivalent on 2019-10-24. Applicant: Ge Hangwei Medical Systems Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ge Hangwei Medical Systems Co., Ltd.
- 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
- Special
- Location
- Beijing Economic & Technological Develop, CN
Recent devices under product code JAK
view allMore clearances from Ge Hangwei Medical Systems Co., Ltd.
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 K192686
K-number listed on FDA's recall record- Z-0603-2025 — GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
- Z-0606-2025 — GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
- Z-0610-2025 — GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
- Z-0611-2025 — GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
- Z-0612-2025 — GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192686.
Data sourced from openFDA. This site is unofficial and independent of the FDA.