Cleared Traditional

MOSAIQ Oncology Information System

K203172 · Elekta Solutions AB · Radiology
Dec 2020
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K203172 is an FDA 510(k) clearance for the MOSAIQ Oncology Information System, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on December 18, 2020, 53 days after receiving the submission on October 26, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K203172 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2020
Decision Date December 18, 2020
Days to Decision 53 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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