FDA.report

510(k) K211720

Device
Planmed Clarity 2D, Planmed Clarify S
Applicant
Planmed OY
510(k) number
K211720
Product code
MUE
Decision
Substantially Equivalent (SESE)
Decision date
2022-07-18
Date received
2021-06-04
Regulation
892.1715
Classification name
Full Field Digital, System, X-Ray, Mammographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Niina Vuorikallas
Address
Sorvaajankatu 7 Helsinki FI 00880 00880

FDA Registration Numbers

Source Documents

510(k) summary PDF

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