Nm/Ct 850, Nm/Ct 860
FDA 510(k) K173816 · GE Healthcare
510(k) numberK173816
Submission
- Device name
- Nm/Ct 850, Nm/Ct 860
- Applicant
- GE Healthcare
Tirat Hacarmel, IL - Received
- December 15, 2017
- Decision date
- April 17, 2018
- 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 |
|---|---|---|
| K253639 | ViewLLZ · Traditional | 01/08/2026SE |
| K242925 | MR Contour DLQKB · Traditional | 04/01/2025SE |
| K241300 | ViewPoint 6LLZ · Traditional | 07/02/2024SE |
| K232346 | Digital Expert Access with Remote ScanningLNH · Traditional | 10/27/2023SE |
| K223212 | Precision DLKPS · Traditional | 04/27/2023SE |
| K221680 | Xeleris V Processing and Review SystemLLZ · Traditional | 03/01/2023SE |
| K221932 | Omni LegendKPS · Traditional | 09/02/2022SE |
| K213689 | Voluson P6, Voluson P8IYN · Traditional | 02/17/2022SE |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertIYN · Traditional | 01/13/2022SE |
| K211488 | Logiq E10IYN · Traditional | 09/10/2021SE |
Questions and answers
When was Nm/Ct 850, Nm/Ct 860 cleared by the FDA?
Nm/Ct 850, Nm/Ct 860 (K173816) received a 510(k) decision of Substantially Equivalent on April 17, 2018, 123 days after the submission was received.
What is the product code of K173816?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.