Neuroq - PET DP
FDA 510(k) K041022 · Syntermed, Inc.
510(k) numberK041022
Submission
- Device name
- Neuroq - PET DP
- Applicant
- Syntermed, Inc.
Atlanta, GA, US - Received
- April 20, 2004
- Decision date
- June 17, 2004
- 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 |
|---|---|---|
| K223422 | Emory Cardiac Toolbox 4.3KPS · Special | 03/30/2023SE |
| K180077 | NeuroQ 3.8KPS · Traditional | 08/16/2018SE |
| K130902 | Emory Cardiac Toolbox 3.2KPS · Traditional | 06/14/2013SE |
| K130451 | Neuroq 3.6KPS · Traditional | 05/17/2013SE |
| K123646 | Emory Cardiac Toolbox 4.0KPS · Traditional | 02/22/2013SE |
| K072307 | Quantitative Neuroq 3.0KPS · Traditional | 03/14/2008SE |
| K071503 | System, Tomography, Computed EmissionKPS · Traditional | 07/26/2007SE |
| K070089 | Syntermed LiveLLZ · Traditional | 03/02/2007SE |
| K042258 | Bp-Spect V1.OKPS · Traditional | 10/04/2004SE |
| K040141 | Emory Cardiac Toolbox Version 2.6KPS · Traditional | 01/30/2004SE |
Questions and answers
When was Neuroq - PET DP cleared by the FDA?
Neuroq - PET DP (K041022) received a 510(k) decision of Substantially Equivalent on June 17, 2004, 58 days after the submission was received.
What is the product code of K041022?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.