Vereos PET/CT
FDA 510(k) K211764 · Philips Medical Systems Nederland B.V.
510(k) numberK211764
Submission
- Device name
- Vereos PET/CT
- Applicant
- Philips Medical Systems Nederland B.V.
Best, NL - Received
- June 8, 2021
- Decision date
- August 6, 2021
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K254205 | Zenition 30OWB · Traditional | 08/07/2026SE |
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…MOS · Special | 07/30/2026SE |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…MOS · Special | 07/24/2026SE |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional | 05/27/2026SE |
| K253614 | EchoNavigator R5.0QIH · Traditional | 03/17/2026SE |
| K260169 | AV Cardiac CTJAK · Traditional | 03/05/2026SE |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR…LNH · Abbreviated | 02/23/2026SE |
| K253735 | AV VascularQIH · Traditional | 01/22/2026SE |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS · Special | 01/14/2026SE |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubDQK · Abbreviated | 10/24/2025SE |
Questions and answers
When was Vereos PET/CT cleared by the FDA?
Vereos PET/CT (K211764) received a 510(k) decision of Substantially Equivalent on August 6, 2021, 59 days after the submission was received.
What is the product code of K211764?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.