STARSPEED SERIES CT SCANNER SYSTEMS— 510(k) K052855
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K052855 for STARSPEED SERIES CT SCANNER SYSTEMS, Substantially Equivalent on 2005-10-28. Applicant: GE Healthcare. Device class: 2.
Clearance details
- Applicant
- GE Healthcare
- 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 Healthcare
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 K052855
K-number listed on FDA's recall record- Z-0614-2025 — GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite Select; X-ray/computed tomography system
- Z-2587-2018 — CT Goldseal BrightSpeed 16 PWR TIO 2 YR
- Z-2188-2017 — GE Healthcare BrightSpeed X-ray system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052855.
Data sourced from openFDA. This site is unofficial and independent of the FDA.