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510(k) K232491

CT 5300 by Philips Healthcare (Suzhou) Co., Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2024
Date Received
August 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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  • K211168 — Philips Incisive CT on Trailer (November 22, 2021)
  • K203514 — Precise Position (June 17, 2021)
  • K201640 — DuraDiagnost (July 9, 2020)
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  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
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