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510(k) K241266

Imaging system of positron emission and X-ray computed tomography (DigitMI 930) by Raysolution Healthcare Co., Ltd. — Product Code KPS

K241266 is an FDA 510(k) premarket notification submitted by Raysolution Healthcare Co., Ltd. for the device "Imaging system of positron emission and X-ray computed tomography (DigitMI 930)". The FDA issued a decision of Substantially Equivalent on January 27, 2025. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2025
Date Received
May 6, 2024
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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  • K253564 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo (February 13, 2026)
  • K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (January 13, 2026)
  • K253844 — AnyScan 3.0 NM Scanner Family (December 30, 2025)
  • K251370 — Cartesion Prime (PCD-1000A/3) V10.21 (December 1, 2025)
  • 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)

FDA data resources