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FDA 510(k)

Radialis PET Camera

K-Number: K214062 · 2022-02-04

ApplicantRadialis, Inc.
Decision Date2022-02-04
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Radialis PET Camera is a medical device manufactured by Radialis, Inc.. It received FDA 510(k) clearance on 2022-02-04 under approval number K214062. 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 Radialis PET Camera?

Radialis PET Camera is a medical device that received FDA 510(k) clearance on 2022-02-04. It is manufactured by Radialis, Inc.. The 510(k) number is K214062.

When was Radialis PET Camera approved by the FDA?

Radialis PET Camera received FDA 510(k) clearance on 2022-02-04, under approval number K214062.

What company makes Radialis PET Camera?

Radialis PET Camera is manufactured by Radialis, Inc..

What is the FDA product code for Radialis PET Camera?

The FDA product code for Radialis PET Camera 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 →

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