Aurora

FDA 510(k) K251153 · Ge Medical Systems Israel

Substantially Equivalent

510(k) numberK251153

Submission

Device name
Aurora
Applicant
Ge Medical Systems Israel
Tirat Hacarmel, IL
Received
April 14, 2025
Decision date
June 12, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPS – System, Tomography, Computed, Emission
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1200
Specialty
Radiology

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K261305Micsi-PetKPS · Traditional Microstructure Imaging, Inc.09/11/2026SE
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K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…KPS · Special Siemens Medical Solutions USA, Inc.05/21/2026SE
K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional Shanghai United Imaging Healthcare Co., Ltd.04/03/2026SE
K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional Shanghai United Imaging Healthcare Co., Ltd.02/13/2026SE
K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…KPS · Special Spectrum Dynamics Medical, Ltd.01/13/2026SE
K253844AnyScan 3.0 NM Scanner FamilyKPS · Traditional Mediso Medical Imaging Systems, Ltd.12/30/2025SE
K251370Cartesion Prime (PCD-1000A/3) V10.21KPS · Traditional Canon Medical Systems Corporation12/01/2025SE
K251401PennPET Explorer Positron Emission TomographKPS · Traditional Trustees of the University of Pennsylvania11/25/2025SE
K252477Hybrid Viewer (00859873006240)KPS · Special Hermes Medical Solutions AB09/09/2025SE

More from Hermes Medical Solutions AB

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Questions and answers

When was Aurora cleared by the FDA?

Aurora (K251153) received a 510(k) decision of Substantially Equivalent on June 12, 2025, 59 days after the submission was received.

What is the product code of K251153?

The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.