Mammography Color Display DP-M3010

FDA 510(k) K143718 · Canon, Inc.

Substantially Equivalent

510(k) numberK143718

Submission

Device name
Mammography Color Display DP-M3010
Applicant
Canon, Inc.
Hiratsuka-Shi, JP
Received
December 29, 2014
Decision date
January 22, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PGY – Display, Diagnostic Radiology
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

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Questions and answers

When was Mammography Color Display DP-M3010 cleared by the FDA?

Mammography Color Display DP-M3010 (K143718) received a 510(k) decision of Substantially Equivalent on January 22, 2015, 24 days after the submission was received.

What is the product code of K143718?

The FDA product code is PGY – Display, Diagnostic Radiology, a Class II (moderate risk) device regulated under 21 CFR 892.2050.