Solas OR

FDA 510(k) K213691 · Cirdan Imaging, Ltd.

Substantially Equivalent

510(k) numberK213691

Submission

Device name
Solas OR
Applicant
Cirdan Imaging, Ltd.
Lisburn, GB
Received
November 23, 2021
Decision date
December 22, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
MWP – Cabinet, X-Ray System
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1680
Specialty
Radiology

Other 510(k)s with product code MWP

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K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)MWP · Traditional Compai Healthcare (Suzhou) Co.,Ltd04/24/2023SE
K230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)MWP · Traditional Compai Healthcare (Suzhou) Co.,Ltd04/24/2023SE
K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemMWP · Special Kub Technologies, Inc.09/20/2021SE
K210957Kubec Xpert 80 Radiography SystemMWP · Special Kub Technologies, Inc.08/31/2021SE
K210956Kubtec Mozart (XPERT42)MWP · Special Kub Technologies, Inc.08/31/2021SE
K202713TrueView 100 ProMWP · Traditional Compai Healthcare (Shenzhen) Co.,Ltd11/18/2020SE
K200756Kubtec Mozart SupraMWP · Traditional Kub Technologies, Inc.06/12/2020SE
K192939Volumetric Specimen ImagerMWP · Traditional Clarix Imaging12/27/2019SE
K193317CoreLite X-Ray Specimen CabinetMWP · Traditional Cirdan Imaging Limited12/13/2019SE
K183624Kubtec Mozart (Xpert42)MWP · Traditional Kub Technologies, Inc.06/20/2019SE

More from Kub Technologies, Inc.

510(k)DeviceDecision
K193317CoreLite X-Ray Specimen CabinetMWP · Traditional 12/13/2019SE

Questions and answers

When was Solas OR cleared by the FDA?

Solas OR (K213691) received a 510(k) decision of Substantially Equivalent on December 22, 2021, 29 days after the submission was received.

What is the product code of K213691?

The FDA product code is MWP – Cabinet, X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1680.