ES/ULTRA DISPLAY AND PROCESSING STATION— 510(k) K905412

Name: FDA 510(k) clearance K905412
Creator: U.S. Food and Drug Administration
Published: 1991-03-25

Substantially Equivalent

Toshiba America Medical Systems, In.C

FDA 510(k) clearance K905412 for ES/ULTRA DISPLAY AND PROCESSING STATION, Substantially Equivalent on 1991-03-25. Applicant: Toshiba America Medical Systems, In.C. Device class: 1.

Clearance details

Applicant: Toshiba America Medical Systems, In.C
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 1990-12-03
Decision date: 1991-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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