Symbia SPECT and SPECT/CT Systems
K-Number: K241898 · 2024-07-26
ApplicantSiemens Healthineers
Decision Date2024-07-26
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Symbia SPECT and SPECT/CT Systems is a medical device manufactured by Siemens Healthineers. It received FDA 510(k) clearance on 2024-07-26 under approval number K241898. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Symbia SPECT and SPECT/CT Systems?
Symbia SPECT and SPECT/CT Systems is a medical device that received FDA 510(k) clearance on 2024-07-26. It is manufactured by Siemens Healthineers. The 510(k) number is K241898.
When was Symbia SPECT and SPECT/CT Systems approved by the FDA?
Symbia SPECT and SPECT/CT Systems received FDA 510(k) clearance on 2024-07-26, under approval number K241898.
What company makes Symbia SPECT and SPECT/CT Systems?
Symbia SPECT and SPECT/CT Systems is manufactured by Siemens Healthineers.
What is the FDA product code for Symbia SPECT and SPECT/CT Systems?
The FDA product code for Symbia SPECT and SPECT/CT Systems is KPS.
Related Clinical Trials
Other Devices by Siemens Healthineers
Related Devices (Code: KPS)
K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.
K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc.
K161674QuantumCamDdd-Diagnostic A/S
K162337Symbia 6.5Siemens Medical Solutions USA, Inc.
K161574Discovery MIGe Medical Systems, LLC
K161631MAMMIGeneral Equipment For Medical Imaging
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.