OPTIMA CT520— 510(k) K123596
Substantially EquivalentGe Hangwei Medical Systems Co., Ltd.
FDA 510(k) clearance K123596 for OPTIMA CT520, Substantially Equivalent on 2013-02-08. 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
- Traditional
- Location
- Beijing, 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 K123596
K-number listed on FDA's recall record- Z-0601-2025 — GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
- Z-0604-2025 — GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
- Z-2585-2018 — Optima CT 520
- Z-2185-2017 — GE Healthcare Optima CT520 X-ray system
- Z-0840-2014 — GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123596.
Data sourced from openFDA. This site is unofficial and independent of the FDA.