ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200— 510(k) K061538

Name: FDA 510(k) clearance K061538
Creator: U.S. Food and Drug Administration
Published: 2006-06-30

Substantially Equivalent

Alara, Inc.

FDA 510(k) clearance K061538 for ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200, Substantially Equivalent on 2006-06-30. Applicant: Alara, Inc.. Device class: 2.

Clearance details

Applicant: Alara, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2006-06-02
Decision date: 2006-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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