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FDA 510(k)

Biograph Vision, Biograph mCT Family of PET/CTs

K-Number: K193248 · 2020-02-14

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-02-14
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biograph Vision, Biograph mCT Family of PET/CTs is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-02-14 under approval number K193248. 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, Biograph mCT Family of PET/CTs?

Biograph Vision, Biograph mCT Family of PET/CTs is a medical device that received FDA 510(k) clearance on 2020-02-14. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K193248.

When was Biograph Vision, Biograph mCT Family of PET/CTs approved by the FDA?

Biograph Vision, Biograph mCT Family of PET/CTs received FDA 510(k) clearance on 2020-02-14, under approval number K193248.

What company makes Biograph Vision, Biograph mCT Family of PET/CTs?

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

What is the FDA product code for Biograph Vision, Biograph mCT Family of PET/CTs?

The FDA product code for Biograph Vision, Biograph mCT Family of PET/CTs 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

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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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