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)

VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE

K-Number: K974130 · 1998-01-29

Decision Date1998-01-29
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Dejarnette Research Systems. It received FDA 510(k) clearance on 1998-01-29 under 510(k) number K974130. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE?

VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE is a medical device that received FDA 510(k) clearance on 1998-01-29. The listed applicant is Dejarnette Research Systems. The 510(k) number is K974130.

When did VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE receive FDA 510(k) clearance?

VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE received FDA 510(k) clearance on 1998-01-29, under 510(k) number K974130.

Who is the listed applicant for VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE?

The FDA 510(k) record lists Dejarnette Research Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE?

The FDA product code for VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE is LMD.

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.

Other records listing Dejarnette Research Systems 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.

View all 9 devices →

Related Devices (Code: LMD)

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.

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.

↑