Cleared Traditional

ProKnow DS

K251363 · Elekta Solutions AB · Radiology
Oct 2025
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K251363 is an FDA 510(k) clearance for the ProKnow DS, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on October 8, 2025, 160 days after receiving the submission on May 1, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K251363 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2025
Decision Date October 08, 2025
Days to Decision 160 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050