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FDA 510(k)

Biograph mCT Family of PET/CT Systems

K-Number: K173578 · 2017-12-20

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-12-20
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biograph mCT Family of PET/CT Systems is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-12-20 under approval number K173578. 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 mCT Family of PET/CT Systems?

Biograph mCT Family of PET/CT Systems is a medical device that received FDA 510(k) clearance on 2017-12-20. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K173578.

When was Biograph mCT Family of PET/CT Systems approved by the FDA?

Biograph mCT Family of PET/CT Systems received FDA 510(k) clearance on 2017-12-20, under approval number K173578.

What company makes Biograph mCT Family of PET/CT Systems?

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

What is the FDA product code for Biograph mCT Family of PET/CT Systems?

The FDA product code for Biograph mCT Family of PET/CT Systems is KPS.

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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.

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