510(k) · Cleared

Cleared

cmAngio® (V1.6)

K250754510(k) SpecialCleared Apr 10, 202529-day reviewClass II21 CFR 892.2050

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

Curemetrix, Inc. · QIH Automated Radiological Image Processing Software

Cleared on Apr 10, 2025 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Apr 10, 2025
Review: 29 days
Class: Class II
Product code: QIH
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK250754 cmAngio® (V1.6)Curemetrix, Inc. · 2025
Descendant · cites it directly · 0 of its ownK254131 BACDeepHealth, Inc. · 2026

Most influential descendants

Showing 1 of 1 · See all

K254131BACDeepHealth, Inc. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K250754	cmAngio® (V1.6)	Curemetrix, Inc.	2025	—
+1	K254131	BAC	DeepHealth, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K250754, 2025–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in QIH? 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 QIH device

#1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K254131	BAC	DeepHealth, Inc.	2026	0

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?

Of its descendants, K254131 (DeepHealth, Inc., 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All QIH devices

QIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · QIH

94in 2025

2007high 94 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QIH

150in 2025

2007high 151 (2023) · low 125 (2021)2026

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

Recalls per year · QIH

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QIH

4in 2025

2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	2	—	0	0
2020	11	145	0	0
2021	19	125	0	0
2022	25	134	0	0
2023	45	151	0	0
2024	64	141	0	2
2025	94	150	0	4
2026	78	130	1	—

What is it indicated for?

cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast…

Read the full statement (133 words)

cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC).

cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC.

The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K250754 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250754: cmAngio® (V1.6).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250754

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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