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 whole body SPECT/CT system

K-Number: K182484 · 2018-11-09

ApplicantSpectrum Dynamics Medical, Ltd.
Decision Date2018-11-09
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 2018-11-09 under approval number K182484. 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 2018-11-09. It is manufactured by Spectrum Dynamics Medical, Ltd.. The 510(k) number is K182484.

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 2018-11-09, under approval number K182484.

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

NCT07399574 Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples NOT_YET_RECRUITING NCT05513027 Augmented Whole-body Scanning Via Magnifying PET/CT (AWSM-PET/CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the Standard-of-care (SOC) PET/CT for Malignant Lesion Detection TERMINATED NCT07572318 Pilot Study on the Feasibility of High-energy Collimation With Optimized Geometry on a VERITON™ CZT Camera NOT_YET_RECRUITING NCT07563309 A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test RECRUITING NCT05286814 PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma RECRUITING NCT07556198 Effects of Whole-Body Vibration With Foot Core Exercises: A Randomized Controlled Trial COMPLETED

Other Devices by Spectrum Dynamics Medical, Ltd.

K161740D-SPECT Scanner, D-SPECT L Scanner 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

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.

↑