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510(k) K151403

Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System by Neusoft Medical Systems Co., Ltd. — Product Code KPS

K151403 is an FDA 510(k) premarket notification submitted by Neusoft Medical Systems Co., Ltd. for the device "Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System". The FDA issued a decision of Substantially Equivalent on November 2, 2015. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Neusoft Medical Systems Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2015
Date Received
May 26, 2015
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

Other clearances by Neusoft Medical Systems Co., Ltd.

  • K230220 — NeuViz 128 Multi-Slice CT Scanner System (October 11, 2023)
  • K171198 — NeuViz 16 Essence Multi-slice CT Scanner System (December 7, 2017)
  • K171201 — NeuViz Prime Multi-slice CT Scanner System (September 13, 2017)
  • K151383 — NeuViz 128 Multi-slice CT Scanner System (November 4, 2015)
  • K133373 — CLEARVIEW (December 3, 2014)
  • K121792 — NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM (November 16, 2012)
  • K110077 — NEUCOLONCARE (January 28, 2011)
  • K102435 — BEYONDIMAGE WORKSTATION (October 15, 2010)
  • K092742 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (September 22, 2009)
  • K092237 — NSM-S15 SYSTEM (September 9, 2009)

Other clearances for product code KPS

  • K261427 — uMI Panvivo (uMI Panvivo M) (July 28, 2026)
  • K261315 — Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.spect (May 21, 2026)
  • K260524 — uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panviv (April 3, 2026)
  • 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)

FDA data resources