FDA 510(k) clearance · back to tracker

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

Dejarnette Research Systems cleared K974130 on 1998-01-29, decision: substantially equivalent

K-number

K974130

Sponsor

Dejarnette Research Systems

Device

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

Class

Class I

Decision

Substantially Equivalent

Decision date

1998-01-29

Product code

LMD

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.2020

Official FDA record

Open K974130on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K974130 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.