Cleared Traditional

Planmed Clarity 2D, Planmed Clarify S

K211720 · Planmed OY · Radiology

Jul 2022

Decision

409d

Days

Class 2

Risk

About This 510(k) Submission

K211720 is an FDA 510(k) clearance for the Planmed Clarity 2D, Planmed Clarify 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 July 18, 2022, 409 days after receiving the submission on June 4, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number	K211720 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2021
Decision Date	July 18, 2022
Days to Decision	409 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF