GE Vision Nuclear Medicine Workstation
FDA 510(k) K012568 · General Electric Co.
510(k) numberK012568
Submission
- Device name
- GE Vision Nuclear Medicine Workstation
- Applicant
- General Electric Co.
Twinsburg, OH, US - Received
- August 9, 2001
- Decision date
- September 6, 2001
- 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 |
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| K110798 | Senographe DS, Senographe EssentialMUE · Traditional | 12/22/2011SE |
| K103485 | Senograph DS, Senograph EssenstialMUE · Traditional | 10/06/2011SE |
| K103489 | GE Veo Reconstruction OptionJAK · Traditional | 09/09/2011SE |
| K082317 | GE Lunar Frax 10-YEAR Fracture Risk Software OptionKGI · Traditional | 09/26/2008SE |
| K081921 | GE Vivid E9 UltrasoundIYN · Special | 08/06/2008SE |
| K073297 | GE Logiq P6IYN · Special | 12/18/2007SE |
| K072952 | GE EchopacLLZ · Special | 11/16/2007SE |
| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
| K071985 | GE Vivid S5 and S6 Diagnostic UltrasoundIYN · Special | 08/17/2007SE |
Questions and answers
When was GE Vision Nuclear Medicine Workstation cleared by the FDA?
GE Vision Nuclear Medicine Workstation (K012568) received a 510(k) decision of Substantially Equivalent on September 6, 2001, 28 days after the submission was received.
What is the product code of K012568?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.