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FDA 510(k)

Biograph Vision Quadra PET/CT System

K-Number: K210262 · 2021-03-03

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-03-03
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biograph Vision Quadra PET/CT System is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-03-03 under approval number K210262. 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 Quadra PET/CT System?

Biograph Vision Quadra PET/CT System is a medical device that received FDA 510(k) clearance on 2021-03-03. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K210262.

When was Biograph Vision Quadra PET/CT System approved by the FDA?

Biograph Vision Quadra PET/CT System received FDA 510(k) clearance on 2021-03-03, under approval number K210262.

What company makes Biograph Vision Quadra PET/CT System?

Biograph Vision Quadra PET/CT System is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for Biograph Vision Quadra PET/CT System?

The FDA product code for Biograph Vision Quadra PET/CT System is KPS.

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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

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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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