Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems

K-Number: K251671 · 2025-07-03

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2025-07-03
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2025-07-03 under approval number K251671. 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 Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems?

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K251671.

When was Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems approved by the FDA?

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems received FDA 510(k) clearance on 2025-07-03, under approval number K251671.

What company makes Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems?

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems?

The FDA product code for Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems is KPS.

Other Devices by Siemens Medical Solutions USA, Inc.

K162302Somatom Confidence ® RT Pro K162971Multix Fusion Max K161795MAGNETOM ESSENZA K162541syngo Application Software K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT K162370syngo.via RT Image Suite

View all 248 devices →

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.

↑