Microdose Si

FDA 510(k) K123995 · Philips Digital Mammography Sweden AB

Substantially Equivalent

510(k) numberK123995

Submission

Device name
Microdose Si
Applicant
Philips Digital Mammography Sweden AB
Solna, SE
Received
December 26, 2012
Decision date
February 1, 2013
Decision
Substantially Equivalent (SESE)
Type
Special 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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More from Planmed OY

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Questions and answers

When was Microdose Si cleared by the FDA?

Microdose Si (K123995) received a 510(k) decision of Substantially Equivalent on February 1, 2013, 37 days after the submission was received.

What is the product code of K123995?

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.