MOSAIQ Oncology Information System

Accelerator, Linear, Medical

Elekta Solutions AB

The following data is part of a premarket notification filed by Elekta Solutions Ab with the FDA for Mosaiq Oncology Information System.

Pre-market Notification Details

Device IDK203172
510k NumberK203172
Device Name:MOSAIQ Oncology Information System
ClassificationAccelerator, Linear, Medical
Applicant Elekta Solutions AB Kungstensgatan 18, Box 7593 Stockholm,  SE Se-10393
ContactMelinda Smith
CorrespondentThomas Valentine
Elekta, Inc. 400 Perimeter Center Terrance NE, Suite 50 Atlanta,  GA  30346
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-26
Decision Date2020-12-18

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