CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM— 510(k) K082432

Name: FDA 510(k) clearance K082432
Creator: U.S. Food and Drug Administration
Published: 2008-11-21

Substantially Equivalent

Bioptics, Inc.

FDA 510(k) clearance K082432 for CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM, Substantially Equivalent on 2008-11-21. 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: 2008-08-22
Decision date: 2008-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Surprise, AZ, US

Download summary PDF View on FDA.gov ↗

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