Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

K-Number: K230600 · 2023-04-28

ApplicantSpectrum Dynamics Medical, Ltd.
Decision Date2023-04-28
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) is a medical device manufactured by Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2023-04-28 under approval number K230600. 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 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)?

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) is a medical device that received FDA 510(k) clearance on 2023-04-28. It is manufactured by Spectrum Dynamics Medical, Ltd.. The 510(k) number is K230600.

When was VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) approved by the FDA?

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) received FDA 510(k) clearance on 2023-04-28, under approval number K230600.

What company makes VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)?

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) is manufactured by Spectrum Dynamics Medical, Ltd..

What is the FDA product code for VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)?

The FDA product code for VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) is KPS.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07578142 AcceXible Speech-Based Screening for Depression and Anxiety in University Students (UAQ, Mexico) NOT_YET_RECRUITING NCT07194265 A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

Other Devices by Spectrum Dynamics Medical, Ltd.

K161740D-SPECT Scanner, D-SPECT L Scanner K182484VERITON CT whole body SPECT/CT system K180514VERITON NM K190457VERITON CT whole body SPECT/CT system K212230TruSPECT Radiological Image Processing Station 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.

↑