OS-2000 OPTICAL SONOGRAPHY SYSTEM— 510(k) K001510

Name: FDA 510(k) clearance K001510
Creator: U.S. Food and Drug Administration
Published: 2000-11-30

Substantially Equivalent

Advanced Diagnostics, Inc.

FDA 510(k) clearance K001510 for OS-2000 OPTICAL SONOGRAPHY SYSTEM, Substantially Equivalent on 2000-11-30. Applicant: Advanced Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Diagnostics, Inc.
Product code: Code NCS
Device class: Class 2
Regulation: 21 CFR 892.1550
Advisory panel: Radiology
Date received: 2000-05-15
Decision date: 2000-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richland, WA, US

Download summary PDF View on FDA.gov ↗

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