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FDA 510(k)

BBX-PET Scanner

K-Number: K210450 · 2021-03-17

ApplicantPrescient Imaging, LLC
Decision Date2021-03-17
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BBX-PET Scanner is a medical device manufactured by Prescient Imaging, LLC. It received FDA 510(k) clearance on 2021-03-17 under approval number K210450. 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 BBX-PET Scanner?

BBX-PET Scanner is a medical device that received FDA 510(k) clearance on 2021-03-17. It is manufactured by Prescient Imaging, LLC. The 510(k) number is K210450.

When was BBX-PET Scanner approved by the FDA?

BBX-PET Scanner received FDA 510(k) clearance on 2021-03-17, under approval number K210450.

What company makes BBX-PET Scanner?

BBX-PET Scanner is manufactured by Prescient Imaging, LLC.

What is the FDA product code for BBX-PET Scanner?

The FDA product code for BBX-PET Scanner is KPS.

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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