ImagenSPECT 3.0
FDA 510(k) K201933 · Cardiovascular Imaging Technologies
510(k) numberK201933
Submission
- Device name
- ImagenSPECT 3.0
- Applicant
- Cardiovascular Imaging Technologies
Kansas City, MO, US - Received
- July 13, 2020
- Decision date
- August 11, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K173547 | ImagenUniversalKPS · Traditional | 01/12/2018SE |
| K152503 | ImagenSPECTKPS · Traditional | 01/25/2016SE |
| K122241 | IMAGEN3DKPS · Traditional | 10/24/2012SE |
| K080770 | Imagenmd with ImagenqLLZ · Traditional | 04/09/2008SE |
| K050366 | ImagenproKPS · Traditional | 03/17/2005SE |
| K041671 | ImagenmdKPS · Traditional | 07/22/2004SE |
Questions and answers
When was ImagenSPECT 3.0 cleared by the FDA?
ImagenSPECT 3.0 (K201933) received a 510(k) decision of Substantially Equivalent on August 11, 2020, 29 days after the submission was received.
What is the product code of K201933?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.