BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM— 510(k) K091558

Name: FDA 510(k) clearance K091558
Creator: U.S. Food and Drug Administration
Published: 2009-07-17

Substantially Equivalent

Bioptics, Inc.

FDA 510(k) clearance K091558 for BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM, Substantially Equivalent on 2009-07-17. Applicant: Bioptics, Inc.. Device class: 2.

Clearance details

Applicant: Bioptics, Inc.
Product code: Code MWP
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2009-05-28
Decision date: 2009-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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