Cleared Traditional

PLANMED VERITY

K121418 · Planmed OY · Radiology
Feb 2013
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K121418 is an FDA 510(k) clearance for the PLANMED VERITY, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on February 1, 2013, 266 days after receiving the submission on May 11, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K121418 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2012
Decision Date February 01, 2013
Days to Decision 266 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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