# K221868: QOCA image Smart CXR Image Processing System

- Pathway: 510(k) (Traditional)
- Applicant: Quanta Computer, Inc.
- Decided: Jan 27, 2023 after 214 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN170073 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190362: HealthPNX, Zebra Medical Vision, Ltd. (2019) Summary page 6.

## Indications for use
QOCA® image Smart CXR Image Processing System is a software as medical device (SaMD) used, through artificial intelligence/deep learning technology, to analyze chest X-ray images of adult patient, and then identify cases with suspected pneumothorax. This product shall be used in conjunction with Picture Archiving and Communication System (PACS) at the hospital. This product will automatically analyze the DICOM files automatically pushed from PACS, and then make a notation next to the cases with suspected pneumothorax. This product is only used to remind radiologists to prioritize reviewing cases with suspected pneumothorax. Its results cannot be used as a substitute for a diagnosis by a radiologist, nor can it be used on a stand-alone basis for clinical decision-making.

Source page: https://510kreport.com/device/K221868
Methodology: https://510kreport.com/methodology