FDA 510(k) clearance · back to tracker

BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY

Barco NV Display Systems cleared K980541 on 1998-04-09, decision: substantially equivalent

K-number

K980541

Sponsor

Barco NV Display Systems

Device

BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY

Class

Class I

Decision

Substantially Equivalent

Decision date

1998-04-09

Product code

LMD

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.2020

Official FDA record

Open K980541on accessdata.fda.gov →

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

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Source

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