FDA.report

510(k) K223209

Device
Elekta Unity
Applicant
Elekta Solutions AB
510(k) number
K223209
Product code
IYE
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-23
Date received
2022-10-17
Regulation
892.5050
Classification name
Accelerator, Linear, Medical
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Melinda Smith
Address
Kungstensgatan 18 Box 7593 Stockholm SE SE10393 SE10393

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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