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FDA 510(k)

EVA (Enhanced Visual Assessment) System

K-Number: K161871 · 2016-12-19

ApplicantMobileodt , Ltd.
Decision Date2016-12-19
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EVA (Enhanced Visual Assessment) System is a medical device manufactured by Mobileodt , Ltd.. It received FDA 510(k) clearance on 2016-12-19 under approval number K161871. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVA (Enhanced Visual Assessment) System?

EVA (Enhanced Visual Assessment) System is a medical device that received FDA 510(k) clearance on 2016-12-19. It is manufactured by Mobileodt , Ltd.. The 510(k) number is K161871.

When was EVA (Enhanced Visual Assessment) System approved by the FDA?

EVA (Enhanced Visual Assessment) System received FDA 510(k) clearance on 2016-12-19, under approval number K161871.

What company makes EVA (Enhanced Visual Assessment) System?

EVA (Enhanced Visual Assessment) System is manufactured by Mobileodt , Ltd..

What is the FDA product code for EVA (Enhanced Visual Assessment) System?

The FDA product code for EVA (Enhanced Visual Assessment) System is HEX.

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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) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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