TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)

Q: What is the product code of K230140?

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

FDA 510(k) K230140 · Compai Healthcare (Suzhou) Co.,Ltd

Substantially Equivalent

510(k) numberK230140

Submission

Device name: TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
Applicant: Compai Healthcare (Suzhou) Co.,Ltd
Suzhou, CN
Received: January 18, 2023
Decision date: April 24, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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

510(k)	Device	Applicant	Decision
K230136	TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)MWP · Traditional	Compai Healthcare (Suzhou) Co.,Ltd	04/24/2023SE
K213691	Solas ORMWP · Traditional	Cirdan Imaging, Ltd.	12/22/2021SE
K210955	Kubtec Mozart Supra (XPERT 84) Radiography SystemMWP · Special	Kub Technologies, Inc.	09/20/2021SE
K210957	Kubec Xpert 80 Radiography SystemMWP · Special	Kub Technologies, Inc.	08/31/2021SE
K210956	Kubtec Mozart (XPERT42)MWP · Special	Kub Technologies, Inc.	08/31/2021SE
K202713	TrueView 100 ProMWP · Traditional	Compai Healthcare (Shenzhen) Co.,Ltd	11/18/2020SE
K200756	Kubtec Mozart SupraMWP · Traditional	Kub Technologies, Inc.	06/12/2020SE
K192939	Volumetric Specimen ImagerMWP · Traditional	Clarix Imaging	12/27/2019SE
K193317	CoreLite X-Ray Specimen CabinetMWP · Traditional	Cirdan Imaging Limited	12/13/2019SE
K183624	Kubtec Mozart (Xpert42)MWP · Traditional	Kub Technologies, Inc.	06/20/2019SE

More from Kub Technologies, Inc.

510(k)	Device	Decision
K230136	TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)MWP · Traditional	04/24/2023SE

Questions and answers

When was TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) cleared by the FDA?

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) (K230140) received a 510(k) decision of Substantially Equivalent on April 24, 2023, 96 days after the submission was received.

What is the product code of K230140?

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