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FDA 510(k)

VERITON CT whole body SPECT/CT system

K-Number: K190457 · 2019-07-12

ApplicantSpectrum Dynamics Medical, Ltd.
Decision Date2019-07-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERITON CT whole body SPECT/CT system is a medical device manufactured by Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2019-07-12 under approval number K190457. 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 VERITON CT whole body SPECT/CT system?

VERITON CT whole body SPECT/CT system is a medical device that received FDA 510(k) clearance on 2019-07-12. It is manufactured by Spectrum Dynamics Medical, Ltd.. The 510(k) number is K190457.

When was VERITON CT whole body SPECT/CT system approved by the FDA?

VERITON CT whole body SPECT/CT system received FDA 510(k) clearance on 2019-07-12, under approval number K190457.

What company makes VERITON CT whole body SPECT/CT system?

VERITON CT whole body SPECT/CT system is manufactured by Spectrum Dynamics Medical, Ltd..

What is the FDA product code for VERITON CT whole body SPECT/CT system?

The FDA product code for VERITON CT whole body SPECT/CT system is KPS.

Related Clinical Trials

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Other Devices by Spectrum Dynamics Medical, Ltd.

K161740D-SPECT Scanner, D-SPECT L Scanner K182484VERITON CT whole body SPECT/CT system K180514VERITON NM 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

View all 8 devices →

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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