Omni Legend— 510(k) K241665
Substantially EquivalentGe Medical Systems Israel, Functional Imaging
FDA 510(k) clearance K241665 for Omni Legend, Substantially Equivalent on 2024-08-08. Applicant: Ge Medical Systems Israel, Functional Imaging. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Israel, Functional Imaging
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tirat Hacarmel, IL
Recent devices under product code KPS
view allMore clearances from Ge Medical Systems Israel, Functional Imaging
view allRecalls naming K241665
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241665.
Data sourced from openFDA. This site is unofficial and independent of the FDA.