MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205— 510(k) K993598

Name: FDA 510(k) clearance K993598
Creator: U.S. Food and Drug Administration
Published: 2000-01-20

Substantially Equivalent

Vidar Systems Corp.

FDA 510(k) clearance K993598 for MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205, Substantially Equivalent on 2000-01-20. Applicant: Vidar Systems Corp.. Device class: 2.

Clearance details

Applicant: Vidar Systems Corp.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 1999-10-25
Decision date: 2000-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herndon, VA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.