Aurora— 510(k) K251153
Substantially EquivalentGe Medical Systems Israel
FDA 510(k) clearance K251153 for Aurora, Substantially Equivalent on 2025-06-12. Applicant: Ge Medical Systems Israel. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Israel
- 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
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