510(k) K230140
- Device
- TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
- Applicant
- Compai Healthcare (Suzhou) Co.,Ltd
- 510(k) number
- K230140
- Product code
- MWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-24
- Date received
- 2023-01-18
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Xueqiao Wang
- Address
- Rm. 3a05, Bldg. 2, #8 Changting Rd., High-Tech Zone Suzhou CN 215151 215151
FDA Registration Numbers
- 3010478247
- 3006051164
- 3027847687
- 3026962577
- 3005496266
- 3017889703
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 06974970580081 | TrueView | CompAI Healthcare (Suzhou) Co.,ltd | 2023-05-17 |
Other 510(k) Records For Product Code MWP
| 510(k) | Device | Applicant | Decision date |
|---|
| K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 |
| K213691 | Solas OR | Cirdan Imaging, Ltd. | 2021-12-22 |
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | 2021-09-20 |
| K210957 | Kubec Xpert 80 Radiography System | Kub Technologies, Inc. | 2021-08-31 |
| K210956 | Kubtec Mozart (XPERT42) | Kub Technologies, Inc. | 2021-08-31 |
| K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | 2020-11-18 |
| K200756 | Kubtec Mozart Supra | Kub Technologies, Inc. | 2020-06-12 |
| K192939 | Volumetric Specimen Imager | Clarix Imaging | 2019-12-27 |
| K193317 | CoreLite X-Ray Specimen Cabinet | Cirdan Imaging Limited | 2019-12-13 |
| K183624 | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | 2019-06-20 |
| K183142 | PathVisionXL | Faxitron Bioptics, LLC | 2019-03-14 |
| K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | 2019-01-10 |
| K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | 2018-05-09 |
| K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | 2017-07-18 |
| K153583 | BioVision Plus | Faxitron Bioptics, LLC | 2016-04-01 |