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

FDA 510(k)

VISIA DYNAMIC REVIEW

K-Number: K113337 · 2011-12-30

ApplicantMeVis Medical Solutions AG
Decision Date2011-12-30
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISIA DYNAMIC REVIEW is the device name listed in this FDA 510(k) record. The listed applicant is MeVis Medical Solutions AG. It received FDA 510(k) clearance on 2011-12-30 under 510(k) number K113337. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIA DYNAMIC REVIEW?

VISIA DYNAMIC REVIEW is a medical device that received FDA 510(k) clearance on 2011-12-30. The listed applicant is MeVis Medical Solutions AG. The 510(k) number is K113337.

When did VISIA DYNAMIC REVIEW receive FDA 510(k) clearance?

VISIA DYNAMIC REVIEW received FDA 510(k) clearance on 2011-12-30, under 510(k) number K113337.

Who is the listed applicant for VISIA DYNAMIC REVIEW?

The FDA 510(k) record lists MeVis Medical Solutions AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISIA DYNAMIC REVIEW?

The FDA product code for VISIA DYNAMIC REVIEW is LNH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing MeVis Medical Solutions AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260576MeVis AVM ContourK232045MeVis Liver SuiteK201501VeolityK120207VISIAK120484VISIA ONCOLOGYK113701VISIA NEURO

View all 7 devices →

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K261283APERTO Lucent MRI SystemFujifilm CorporationK260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems

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.

↑