Cleared Traditional

K143718 - Mammography Color Display DP-M3010

K143718 is the FDA 510(k) clearance for Mammography Color Display DP-M3010 by Canon, Inc.. It is a Class 2 Radiology device (product code PGY) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K143718 · Canon, Inc. · Radiology device
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Jan 2015
Decision
24d
Days
Class 2
Risk

K143718 is an FDA 510(k) clearance for the Mammography Color Display DP-M3010. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Canon, Inc. (Hiratsuka-Shi, JP). The FDA issued a Cleared decision on January 22, 2015 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Canon, Inc. devices

Submission Details

510(k) Number K143718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date January 22, 2015
Days to Decision 24 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Mic International Corp.
IZUMI MARUO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.