Symbia SPECT and SPECT/CT Systems
FDA 510(k) K241898 · Siemens Healthineers
510(k) numberK241898
Submission
- Device name
- Symbia SPECT and SPECT/CT Systems
- Applicant
- Siemens Healthineers
Knoxville, TN, US - Received
- June 28, 2024
- Decision date
- July 26, 2024
- 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 |
|---|---|---|
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional | 07/31/2026SE |
| K253690 | LungMapsQIH · Traditional | 06/15/2026SE |
| K253023 | BIOGRAPH OneOUO · Traditional | 01/15/2026SE |
| K253495 | syngo.MR Applications (VB80)LLZ · Traditional | 11/20/2025SE |
| K251059 | Syngo Carbon Clinicals (VA41)QIH · Traditional | 10/24/2025SE |
| K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound SystemIYN · Traditional | 03/20/2019SE |
Questions and answers
When was Symbia SPECT and SPECT/CT Systems cleared by the FDA?
Symbia SPECT and SPECT/CT Systems (K241898) received a 510(k) decision of Substantially Equivalent on July 26, 2024, 28 days after the submission was received.
What is the product code of K241898?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.