510(k) · Cleared

Cleared

QOCA image Smart CXR Image Processing System

K221868510(k) TraditionalCleared Jan 27, 2023214-day reviewClass II21 CFR 892.2080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Quanta Computer, Inc. · QFM Radiological Computer-Assisted Prioritization Software For Lesions

Cleared on Jan 27, 2023 as substantially equivalent to K190362 (Zebra Medical Vision, Ltd., 2019) after a 214-day review. Its family tree reaches back 3 generations to 2018.

Decided: Jan 27, 2023
Review: 214 days
Class: Class II
Product code: QFM
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to DEN170073 (2018). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
2 generations backK183285 cmTriageCuremetrix, Inc. · 2019
1 generation backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
This deviceK221868 QOCA image Smart CXR Image Processing SystemQuanta Computer, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	DEN170073	ContaCT	Viz.Al, Inc.	2018	—
−2	K183285	cmTriage	Curemetrix, Inc.	2019	—
−1	K190362	HealthPNX	Zebra Medical Vision, Ltd.	2019	—
0 (this device)	K221868	QOCA image Smart CXR Image Processing System	Quanta Computer, Inc.	2023	—

FIG. 1 — Lineage of K221868, 2018–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QFM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QFM device

#1 K211733 Lunit INSIGHT CXR Triagescore 21.2 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K190362	HealthPNX Summary page 6 …ification of the Predicate Device: Predicate Device Name: HealthPNX Model Number: ˇ 510(k) Number: K190362 Manufacturer: Zebra Medical Vision Ltd. Regulation Number: 892.2080 Produ…	Zebra Medical Vision, Ltd.	2019	—

Also cleared against K190362: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
None of the 3 ancestors has a recall.
5 other devices also cite its predicate K190362.

How does its category compare?

All QFM devices

QFM Radiological Computer-Assisted Prioritization Software For Lesions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · QFM

3in 2025

2007high 9 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QFM

100in 2025

2007high 206 (2023) · low 97 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QFM

No recall names QFM since 2007.

Adverse event reports per year · QFM

No MAUDE report names QFM since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	4	97	0
2020	4	172	0
2021	5	187	0
2022	9	121	0
2023	8	206	0
2024	6	192	0
2025	3	100	0
2026	2	—	—

What is it indicated for?

Read the full statement (117 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K221868 · printed Nov 5, 2026

Cite this page

510(k) Report. “K221868: QOCA image Smart CXR Image Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221868

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026