FDA.report

510(k) K251153

Device
Aurora
Applicant
Ge Medical Systems Israel
510(k) number
K251153
Product code
KPS
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-12
Date received
2025-04-14
Regulation
892.1200
Classification name
System, Tomography, Computed, Emission
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Hanne Jubran
Address
Functional Imaging (Ge Healthcare) 4 Hayozma St. Tirat Hacarmel IL 30200 30200

FDA Registration Numbers

Source Documents

510(k) summary PDF

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