TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) (K230136)
Description
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) by Compai Healthcare (Suzhou) Co.,Ltd, an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230136
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) (K230136) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | 2020 |
Trace the full predicate network for K230136
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.