FDA.report

510(k) K253649

Device
Spectral CT Verida Family
Applicant
Philips Medical Systems Technologies , Ltd.
510(k) number
K253649
Product code
JAK
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-27
Date received
2025-11-20
Regulation
892.1750
Classification name
System, X-Ray, Tomography, Computed
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
Siwar Assi
Address
Advanced Technology Center, Matam, Bldg. 34 Haifa IL 3100202 3100202

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code JAK

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K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.2026-01-20
K252217CT VScore+Canon Medical Informatics, Inc.2025-11-28
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K250662Bunkerhill MACBunkerHill Health2025-10-03
K250766LungQ 4Thirona BV2025-10-02
K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAPCanon Medical Systems Corporation2025-09-26