Cardius 1, 2 and 3 Xpo and 2020TC SPECT Imaging Systems
FDA 510(k) K070542 · Digirad Corp.
510(k) numberK070542
Submission
- Device name
- Cardius 1, 2 and 3 Xpo and 2020TC SPECT Imaging Systems
- Applicant
- Digirad Corp.
Poway, CA, US - Received
- February 26, 2007
- Decision date
- March 23, 2007
- 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 |
|---|---|---|
| K123408 | Ergo Imaging SystemIYX · Traditional | 01/15/2013SE |
| K100838 | Ergo Imaging SystemIYX · Special | 04/23/2010SE |
| K083649 | Cardius 3 X-ActKPS · Traditional | 03/09/2009SE |
| K082904 | Stasys Motion Correction SoftwareKPS · Traditional | 12/17/2008SE |
| K082368 | CARDIUS-1, -2, -3, and Cardius 1,2,3 Xpo SPECT Imaging Systems, 2020TC SPECT Imaging…KPS · Special | 09/12/2008SE |
| K052430 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT Imaging SystemKPS · Special | 10/04/2005SE |
| K051549 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT Imaging SystemKPS · Special | 07/13/2005SE |
| K030085 | CARDIUS-1 and CARDIS-2KPS · Special | 02/05/2003SE |
| K023110 | Cedars-Sinai Motion Correction (Moco) Software, Model 111005KPS · Traditional | 11/22/2002SE |
| K011572 | Quantitative Gated SPECT (QGS), Quantitative Perfusion SPECT (QPS)KPS · Traditional | 06/15/2001SE |
Questions and answers
When was Cardius 1, 2 and 3 Xpo and 2020TC SPECT Imaging Systems cleared by the FDA?
Cardius 1, 2 and 3 Xpo and 2020TC SPECT Imaging Systems (K070542) received a 510(k) decision of Substantially Equivalent on March 23, 2007, 25 days after the submission was received.
What is the product code of K070542?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.