Cleared Traditional

Planmed Clarity 2D and Clarity S

K192317 · Planmed OY · Radiology

Oct 2020

Decision

424d

Days

Class 2

Risk

About This 510(k) Submission

K192317 is an FDA 510(k) clearance for the Planmed Clarity 2D and Clarity S, a Full Field Digital, System, X-ray, Mammographic (Class II — Special Controls, product code MUE), submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on October 23, 2020, 424 days after receiving the submission on August 26, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number	K192317 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2019
Decision Date	October 23, 2020
Days to Decision	424 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF