FDA.report

510(k) K213691

Device
Solas OR
Applicant
Cirdan Imaging Ltd
510(k) number
K213691
Product code
MWP  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-22
Date received
2021-11-23
Regulation
892.1680
Classification name
Cabinet, X-ray System
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Paul Matthews
Address
The Green, Tullynacross Rd., Lambeg Lisburn GB BT27 5SR BT27 5SR

FDA Registration Numbers

Source Documents

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

Legacy Summary

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FDA Review

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