GE Discovery Nm/Ct 570C
FDA 510(k) K083504 · Ge Medical Systems F.I. Haifa
510(k) numberK083504
Submission
- Device name
- GE Discovery Nm/Ct 570C
- Applicant
- Ge Medical Systems F.I. Haifa
Tirat Hacarmel, IL - Received
- November 26, 2008
- Decision date
- December 12, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K130884 | Xeleris 3.1 Processing and Review WorkstationLLZ · Traditional | 04/12/2013SE |
| K093982 | Xeleris 3 Processing and Review WorkstationLLZ · Traditional | 01/08/2010SE |
| K093514 | Discovery Model Nm/Ct 670KPS · Traditional | 12/10/2009SE |
| K080124 | Ventri 1.1KPS · Traditional | 01/31/2008SE |
| K051855 | VentriKPS · Traditional | 08/02/2005SE |
| K043381 | Infinia LightspeedKPS · Traditional | 12/23/2004SE |
| K033874 | MyolightKPS · Traditional | 12/30/2003SE |
| K023932 | GE Photon Energy Recovery (Per) OptionKPS · Traditional | 12/11/2002SE |
| K022960 | GE Quasar Nuclear Medicine SystemKPS · Traditional | 09/19/2002SE |
| K003264 | Qps/Bpgs/Moco Processing Applications for Entegra WorkstationKPS · Traditional | 12/21/2000SE |
Questions and answers
When was GE Discovery Nm/Ct 570C cleared by the FDA?
GE Discovery Nm/Ct 570C (K083504) received a 510(k) decision of Substantially Equivalent on December 12, 2008, 16 days after the submission was received.
What is the product code of K083504?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.