DIGITAL RADIOGRAPHY— 510(k) K102012

Name: FDA 510(k) clearance K102012
Creator: U.S. Food and Drug Administration
Published: 2010-08-17

Substantially Equivalent

Canon Inc. -Medical Equipment Group

FDA 510(k) clearance K102012 for DIGITAL RADIOGRAPHY, Substantially Equivalent on 2010-08-17. Applicant: Canon Inc. -Medical Equipment Group. Device class: 2.

Clearance details

Applicant: Canon Inc. -Medical Equipment Group
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2010-07-16
Decision date: 2010-08-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Tachikawa-Shi, Tokyo, JP

Download summary PDF View on FDA.gov ↗

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Recalls naming K102012

K-number listed on FDA's recall record

Z-2265-2012 — Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.Class II·Terminated·Canon Inc.·20101101

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102012.

Data sourced from openFDA. This site is unofficial and independent of the FDA.