Mammo Tomosynthesis (MDMG-5221)

FDA 510(k) K161229 · Barco N.V.

Substantially Equivalent

510(k) numberK161229

Submission

Device name
Mammo Tomosynthesis (MDMG-5221)
Applicant
Barco N.V.
Kortrijk, BE
Received
May 2, 2016
Decision date
May 18, 2016
Decision
Substantially Equivalent (SESE)
Type
Special 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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More from Eizo Corporation

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K213957Demetra Dermatoscope BDEM-01PSN · Special 03/11/2022SE
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K203106Nio Fusion 12MP (MDNC-12130)PGY · Special 11/10/2020SE
K192829Demetra BDEM-01 DermatoscopePSN · Traditional 12/13/2019SE
K191845Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools…PGY · Traditional 09/06/2019SE

Questions and answers

When was Mammo Tomosynthesis (MDMG-5221) cleared by the FDA?

Mammo Tomosynthesis (MDMG-5221) (K161229) received a 510(k) decision of Substantially Equivalent on May 18, 2016, 16 days after the submission was received.

What is the product code of K161229?

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