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FDA 510(k)

D-SPECT Scanner, D-SPECT L Scanner

K-Number: K161740 · 2016-11-04

ApplicantSpectrum Dynamics Medical, Ltd.
Decision Date2016-11-04
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

D-SPECT Scanner, D-SPECT L Scanner is a medical device manufactured by Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2016-11-04 under approval number K161740. 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 Scanner, D-SPECT L Scanner?

D-SPECT Scanner, D-SPECT L Scanner is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Spectrum Dynamics Medical, Ltd.. The 510(k) number is K161740.

When was D-SPECT Scanner, D-SPECT L Scanner approved by the FDA?

D-SPECT Scanner, D-SPECT L Scanner received FDA 510(k) clearance on 2016-11-04, under approval number K161740.

What company makes D-SPECT Scanner, D-SPECT L Scanner?

D-SPECT Scanner, D-SPECT L Scanner is manufactured by Spectrum Dynamics Medical, Ltd..

What is the FDA product code for D-SPECT Scanner, D-SPECT L Scanner?

The FDA product code for D-SPECT Scanner, D-SPECT L Scanner is KPS.

Other Devices by Spectrum Dynamics Medical, Ltd.

K182484VERITON CT whole body SPECT/CT system K180514VERITON NM K190457VERITON CT whole body SPECT/CT system K212230TruSPECT Radiological Image Processing Station K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) K253532TruSPECT Processing Station

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Related Devices (Code: KPS)

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 K153056Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB

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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