Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System
FDA 510(k) K151403 · Neusoft Medical Systems Co., Ltd.
510(k) numberK151403
Submission
- Device name
- Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System
- Applicant
- Neusoft Medical Systems Co., Ltd.
Shenyang, CN - Received
- May 26, 2015
- Decision date
- November 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261305 | Micsi-PetKPS · Traditional | Microstructure Imaging, Inc. | 09/11/2026SE |
| K261427 | uMI Panvivo (uMI Panvivo M)KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/28/2026SE |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…KPS · Special | Siemens Medical Solutions USA, Inc. | 05/21/2026SE |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/03/2026SE |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 02/13/2026SE |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…KPS · Special | Spectrum Dynamics Medical, Ltd. | 01/13/2026SE |
| K253844 | AnyScan 3.0 NM Scanner FamilyKPS · Traditional | Mediso Medical Imaging Systems, Ltd. | 12/30/2025SE |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21KPS · Traditional | Canon Medical Systems Corporation | 12/01/2025SE |
| K251401 | PennPET Explorer Positron Emission TomographKPS · Traditional | Trustees of the University of Pennsylvania | 11/25/2025SE |
| K252477 | Hybrid Viewer (00859873006240)KPS · Special | Hermes Medical Solutions AB | 09/09/2025SE |
More from Hermes Medical Solutions AB
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| K230220 | NeuViz 128 Multi-Slice CT Scanner SystemJAK · Traditional | 10/11/2023SE |
| K171198 | NeuViz 16 Essence Multi-slice CT Scanner SystemJAK · Traditional | 12/07/2017SE |
| K171201 | NeuViz Prime Multi-slice CT Scanner SystemJAK · Traditional | 09/13/2017SE |
| K151383 | NeuViz 128 Multi-slice CT Scanner SystemJAK · Traditional | 11/04/2015SE |
| K133373 | ClearviewJAK · Traditional | 12/03/2014SE |
| K121792 | Neuviz 64 Multi-Slice CT Scanner SystemJAK · Traditional | 11/16/2012SE |
| K110077 | NeucoloncareLLZ · Traditional | 01/28/2011SE |
| K102435 | Beyondimage WorkstationLLZ · Traditional | 10/15/2010SE |
| K092742 | Neuviz 16 Multi-Slice CT Scanner SystemJAK · Traditional | 09/22/2009SE |
| K092237 | NSM-S15 SystemLNH · Traditional | 09/09/2009SE |
Questions and answers
When was Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System cleared by the FDA?
Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System (K151403) received a 510(k) decision of Substantially Equivalent on November 2, 2015, 160 days after the submission was received.
What is the product code of K151403?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.