DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS— 510(k) K093581
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K093581 for DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS, Substantially Equivalent on 2011-04-19. Applicant: Ge Medical Systems, LLC. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems, LLC
- 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
- Waukesha, WI, US
Recent devices under product code JAK
view allMore clearances from Ge Medical Systems, LLC
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 K093581
K-number listed on FDA's recall record- Z-0600-2025 — GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
- Z-0613-2025 — GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system
- Z-2184-2017 — GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system
- Z-1245-2014 — GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093581.
Data sourced from openFDA. This site is unofficial and independent of the FDA.