510(k) · Cleared

Cleared

Myomics Q

K211432510(k) TraditionalCleared Nov 23, 2021200-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

Phantomics, Inc. · LLZ System, Image Processing, Radiological

Cleared on Nov 23, 2021 as substantially equivalent to K082628 (Circle Cardiovascular Imaging, Inc., 2008) after a 200-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.

Decided: Nov 23, 2021
Review: 200 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K940172 (1994). 6 ancestors in all, the oldest K924605 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
3 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
2 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
1 generation backK082628 CMR42 Cardiac Mri Imaging System, 2.1.23Circle Cardiovascular Imaging, Inc. · 2008
This deviceK211432 Myomics QPhantomics, Inc. · 2021
Descendant · cites it directly · 0 of its ownK241922 MyomicsPhantomics, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all

K241922MyomicsPhantomics, Inc. · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K940172	Cardiovascular Measurement System-CMS	Medis Medical Imaging Systems, Inc.	1994	—
−3	K993765	Quantitative Analysis of Left Ventricular Angiograms (QLV)	Medis Medical Imaging Systems BV	1999	—
−2	K994283	Mri- Magnetic Resonance Analytical Software System	Medis Medical Imaging Systems BV	2000	—
−1	K082628	CMR42 Cardiac Mri Imaging System, 2.1.23	Circle Cardiovascular Imaging, Inc.	2008	—
0 (this device)	K211432	Myomics Q	Phantomics, Inc.	2021	—
+1	K241922	Myomics	Phantomics, Inc.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K211432, 1994–2025Source: 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 LLZ? 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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
*	K082628	CMR42 Cardiac Mri Imaging System, 2.1.23 Summary page 5 …Inc. Inc. Device Name (Trade Name) cmr42 cvi42 510(k) Number K082628 K141480 4. SUBJECT DEVICE DESCRIPTION Myomics Q is software application for evaluating cardiovascul…	Circle Cardiovascular Imaging, Inc.	2008	—
†	K141480	CVI42	Circle Cardiovascular Imaging, Inc.	2014	—

Also cleared against K082628: 4 other devices →

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
K241922	Myomics	Phantomics, Inc.	2025	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?

The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K241922 (Phantomics, Inc., 2025) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K082628.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

Myomics Q is intended to be used for viewing, post-processing and analysis of cardiac magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables: - Importing cardiac MR images in DICOM format. - Supporting clinical diagnostics by analysis of cardiac MR images using display functionality such as panning, windowing, zooming through series/slices of the images.* - Supporting clinical diagnostics…

Read the full statement (178 words)

- Importing cardiac MR images in DICOM format.

- Supporting clinical diagnostics by analysis of cardiac MR images using display functionality such as panning, windowing, zooming through series/slices of the images.*

- Supporting clinical diagnostics analysis of the heart in cardiac MR images and signal intensity.

- Software package is designed to support the physician-to-physician compliance assessment, document and follow up heart disease by cardiac MRI.

It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. This device is a software application that can be used as a stand-alone product or in a network environment.

The target population for the device is not restricted, however the image acquisition by a cardiac MR scanner may limit the use of the device for certain sectors or the public.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K211432 · printed Nov 6, 2026

Cite this page

510(k) Report. “K211432: Myomics Q.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211432

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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