Class Class II
QOCA image Smart CXR Image Processing System (K221868)
Description
QOCA image Smart CXR Image Processing System by Quanta Computer, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221868
Clearance Date2023-01-27
Clearance TypeTraditional
Product CodeQFM
Regulation Number892.2080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221868
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. QOCA image Smart CXR Image Processing System (K221868) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 |
Trace the full predicate network for K221868
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.