Xact.Cardiac & Xpress.Cardiac
FDA 510(k) K050815 · Ultraspect , Ltd.
510(k) numberK050815
Submission
- Device name
- Xact.Cardiac & Xpress.Cardiac
- Applicant
- Ultraspect , Ltd.
Hafia, IL - Received
- March 31, 2005
- Decision date
- April 26, 2005
- 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 |
|---|---|---|
| K103710 | WBR Xpress PETKPS · Special | 01/19/2011SE |
| K091073 | WBR Xpress.Cardiac and XPRESS3.CARDIAC Including Attenuation and Scattering CorrectionsKPS · Special | 05/14/2009SE |
| K081201 | WBR XPRESS3.CARDIACKPS · Special | 05/28/2008SE |
| K080784 | WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneKPS · Special | 04/02/2008SE |
| K040370 | Wbr-Fhr, Wbr-FwbKPS · Special | 03/11/2004SE |
Questions and answers
When was Xact.Cardiac & Xpress.Cardiac cleared by the FDA?
Xact.Cardiac & Xpress.Cardiac (K050815) received a 510(k) decision of Substantially Equivalent on April 26, 2005, 26 days after the submission was received.
What is the product code of K050815?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.