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FDA 510(k)

AXIS Image Management System

K-Number: K171098 · 2017-05-02

ApplicantSonomed, Inc.
Decision Date2017-05-02
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AXIS Image Management System is a medical device manufactured by Sonomed, Inc.. It received FDA 510(k) clearance on 2017-05-02 under approval number K171098. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIS Image Management System?

AXIS Image Management System is a medical device that received FDA 510(k) clearance on 2017-05-02. It is manufactured by Sonomed, Inc.. The 510(k) number is K171098.

When was AXIS Image Management System approved by the FDA?

AXIS Image Management System received FDA 510(k) clearance on 2017-05-02, under approval number K171098.

What company makes AXIS Image Management System?

AXIS Image Management System is manufactured by Sonomed, Inc..

What is the FDA product code for AXIS Image Management System?

The FDA product code for AXIS Image Management System is NFJ.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (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) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 40061911 Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe. Medical devices (Auckland, N.Z.) (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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