Celesteion, PCA-9000A/3
FDA 510(k) K170490 · Toshibamedical Systems Corporation
510(k) numberK170490
Submission
- Device name
- Celesteion, PCA-9000A/3
- Applicant
- Toshibamedical Systems Corporation
Otawara-Shi, JP - Received
- February 17, 2017
- Decision date
- June 1, 2017
- 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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| K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemIYN · Traditional | 04/20/2018SE |
| K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0JAK · Traditional | 02/23/2018SE |
| K173088 | Vitrea Software Toshiba Package VSTP-001ALLZ · Traditional | 01/31/2018SE |
| K173382 | Vantage Galan 3T, V4.6LNH · Traditional | 01/26/2018SE |
| K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4IYN · Traditional | 01/11/2018SE |
| K172863 | Infinix-i, INFX-8000V, V7.0OWB · Traditional | 12/14/2017SE |
| K172276 | Xario 200 Diagnostic Ultrasound System V6.0IYN · Traditional | 12/12/2017SE |
| K172646 | XIDF-AWS801, Angio Workstation, V7.0OWB · Traditional | 10/30/2017SE |
| K171597 | Vantage Elan 1.5T, V4.0LNH · Traditional | 07/21/2017SE |
| K170832 | Ultimax-i, DREX-UI80 V1.60OWB · Traditional | 07/21/2017SE |
Questions and answers
When was Celesteion, PCA-9000A/3 cleared by the FDA?
Celesteion, PCA-9000A/3 (K170490) received a 510(k) decision of Substantially Equivalent on June 1, 2017, 104 days after the submission was received.
What is the product code of K170490?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.