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510(k) K231762

uEXPLORER by Shanghai United Imaging Healthcare Co., Ltd. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2024
Date Received
June 16, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

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Other clearances for product code KPS

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  • K251401 — PennPET Explorer Positron Emission Tomograph (November 25, 2025)
  • K252477 — Hybrid Viewer (00859873006240) (September 9, 2025)
  • K250170 — PHAROS (August 15, 2025)
  • K251561 — Biograph Trinion (July 31, 2025)
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