Cartesion Prime (PCD-1000A/3) V10.21
FDA 510(k) K251370 · Canon Medical Systems Corporation
510(k) numberK251370
Submission
- Device name
- Cartesion Prime (PCD-1000A/3) V10.21
- Applicant
- Canon Medical Systems Corporation
Otawara-Shi, JP - Received
- May 2, 2025
- Decision date
- December 1, 2025
- 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 |
| 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 |
| K250170 | PharosKPS · Traditional | Brightonix Imaging | 08/15/2025SE |
More from Brightonix Imaging
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| K260078 | Aquilion ServeSP (TSX-307B) V2.0JAK · Traditional | 03/13/2026SE |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)OWB · Traditional | 03/10/2026SE |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemIYN · Traditional | 01/20/2026SE |
| K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemIYN · Traditional | 10/31/2025SE |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingOWB · Traditional | 10/10/2025SE |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…JAK · Traditional | 09/26/2025SE |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional | 07/22/2025SE |
| K243398 | CT Scanner TSX-501R/1 V11.1JAK · Traditional | 06/20/2025SE |
Questions and answers
When was Cartesion Prime (PCD-1000A/3) V10.21 cleared by the FDA?
Cartesion Prime (PCD-1000A/3) V10.21 (K251370) received a 510(k) decision of Substantially Equivalent on December 1, 2025, 213 days after the submission was received.
What is the product code of K251370?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.