Microdose Si

FDA 510(k) K130704 · Philips Digital Mammography Sweden AB

Substantially Equivalent

510(k) numberK130704

Submission

Device name
Microdose Si
Applicant
Philips Digital Mammography Sweden AB
Solna, SE
Received
March 15, 2013
Decision date
December 13, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUE – Full Field Digital, System, X-Ray, Mammographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1715
Specialty
Radiology

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Questions and answers

When was Microdose Si cleared by the FDA?

Microdose Si (K130704) received a 510(k) decision of Substantially Equivalent on December 13, 2013, 273 days after the submission was received.

What is the product code of K130704?

The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.