FDA 510(k)

D-SPECT Processing and Reviewing Workstation

K-Number: K160120 · 2016-03-21

Decision Date2016-03-21

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

D-SPECT Processing and Reviewing Workstation is a medical device manufactured by Spectrum Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-03-21 under approval number K160120. 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 D-SPECT Processing and Reviewing Workstation?

D-SPECT Processing and Reviewing Workstation is a medical device that received FDA 510(k) clearance on 2016-03-21. It is manufactured by Spectrum Dynamics , Ltd.. The 510(k) number is K160120.

When was D-SPECT Processing and Reviewing Workstation approved by the FDA?

D-SPECT Processing and Reviewing Workstation received FDA 510(k) clearance on 2016-03-21, under approval number K160120.

What company makes D-SPECT Processing and Reviewing Workstation?

D-SPECT Processing and Reviewing Workstation is manufactured by Spectrum Dynamics , Ltd..

What is the FDA product code for D-SPECT Processing and Reviewing Workstation?

The FDA product code for D-SPECT Processing and Reviewing Workstation 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.