Cleared Traditional

MOSAIQ? OIS (Oncology Information System)

K223229 · Elekta Solutions AB · Radiology
Feb 2023
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K223229 is an FDA 510(k) clearance for the MOSAIQ? OIS (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 February 23, 2023, 128 days after receiving the submission on October 18, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K223229 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2022
Decision Date February 23, 2023
Days to Decision 128 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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