TrueView 100 Pro
FDA 510(k) K202713 · Compai Healthcare (Shenzhen) Co.,Ltd
510(k) numberK202713
Submission
- Device name
- TrueView 100 Pro
- Applicant
- Compai Healthcare (Shenzhen) Co.,Ltd
Shenzhen, CN - Received
- September 16, 2020
- Decision date
- November 18, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)MWP · Traditional | Compai Healthcare (Suzhou) Co.,Ltd | 04/24/2023SE |
| 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 |
| 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 |
Questions and answers
When was TrueView 100 Pro cleared by the FDA?
TrueView 100 Pro (K202713) received a 510(k) decision of Substantially Equivalent on November 18, 2020, 63 days after the submission was received.
What is the product code of K202713?
The FDA product code is MWP – Cabinet, X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1680.