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)

NeuViz 16 Essence Multi-slice CT Scanner System

K-Number: K171198 · 2017-12-07

ApplicantNeusoft Medical Systems Co., Ltd.
Decision Date2017-12-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NeuViz 16 Essence Multi-slice CT Scanner System is a medical device manufactured by Neusoft Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2017-12-07 under approval number K171198. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuViz 16 Essence Multi-slice CT Scanner System?

NeuViz 16 Essence Multi-slice CT Scanner System is a medical device that received FDA 510(k) clearance on 2017-12-07. It is manufactured by Neusoft Medical Systems Co., Ltd.. The 510(k) number is K171198.

When was NeuViz 16 Essence Multi-slice CT Scanner System approved by the FDA?

NeuViz 16 Essence Multi-slice CT Scanner System received FDA 510(k) clearance on 2017-12-07, under approval number K171198.

What company makes NeuViz 16 Essence Multi-slice CT Scanner System?

NeuViz 16 Essence Multi-slice CT Scanner System is manufactured by Neusoft Medical Systems Co., Ltd..

What is the FDA product code for NeuViz 16 Essence Multi-slice CT Scanner System?

The FDA product code for NeuViz 16 Essence Multi-slice CT Scanner System is JAK.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06578104 PULSED AF Post-Approval Study RECRUITING

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Neusoft Medical Systems Co., Ltd.

K171201NeuViz Prime Multi-slice CT Scanner System K230220NeuViz 128 Multi-Slice CT Scanner System

Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.

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.

↑