Authorized purpose: Myomics assists qualified medical professionals with viewing, post-processing and qualitative/quantitative evaluation of 3T cardiovascular MR images in DICOM format, including heart and adjacent-vessel measurements; semi-automated machine-learning workflows are intended for adults and contribute to comprehensive diagnostic decision-making.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Myomics assists qualified medical professionals with viewing, post-processing and qualitative/quantitative evaluation of 3T cardiovascular MR images in DICOM format, including heart and adjacent-vessel measurements; semi-automated machine-learning workflows are intended for adults and contribute to comprehensive diagnostic decision-making.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Myomics assists qualified medical professionals with viewing, post-processing and qualitative/quantitative evaluation of 3T cardiovascular MR images in DICOM format, including heart and adjacent-vessel measurements; semi-automated machine-learning workflows are intended for adults and contribute to comprehensive diagnostic decision-making.
Which images or clinical context are in scope?Modality: MRI Anatomy or clinical context: Heart/Cardiovascular Input: DICOM cardiovascular MR images acquired at 3.0 T; AI modules cover native/post-contrast T1 maps, T2 maps, CINE, LGE PSIR, CINE RV and LGE magnitude.
Who uses it?Intended users: Qualified medical professionals experienced in examining and evaluating cardiovascular MR images
What does the software produce?Output: Semi-automatic endocardial/epicardial and myocardium segmentation across supported sequences, heart/adjacent-vessel measurements, image display, manual contouring and reports.
What is its most important limitation?Key limitation: Use only cardiac MR images from 3.0 T scanners. Semi-automated ML is intended for adults. Qualified cardiovascular-MR professionals must use results within comprehensive diagnostic assessment.
Clinical takeaway
Clinical role: Myomics assists qualified medical professionals with viewing, post-processing and qualitative/quantitative evaluation of 3T cardiovascular MR images in DICOM format, including heart and adjacent-vessel measurements; semi-automated machine-learning workflows are intended for adults and contribute to comprehensive diagnostic decision-making.
Evidence takeaway
Evidence from the reviewed source record: Exact FDA technical validation is available. Stored cardiac-MR publications require full version review before application to K241922; one unrelated myosin paper is excluded.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Myomics assists qualified medical professionals with viewing, post-processing and qualitative/quantitative evaluation of 3T cardiovascular MR images in DICOM format, including heart and adjacent-vessel measurements; semi-automated machine-learning workflows are intended for adults and contribute to comprehensive diagnostic decision-making.
Hospital or private-practice cardiovascular MR analysis; manual workflows have no stated population restriction, while semi-automated ML workflows are adult-only.
Use only cardiac MR images from 3.0 T scanners. Semi-automated ML is intended for adults. Qualified cardiovascular-MR professionals must use results within comprehensive diagnostic assessment.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Current data flow, access controls, retention, hosting and dated scoped security evidence remain unestablished.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
The FDA specifies experienced cardiovascular-MR users, but vendor onboarding, competency and support commitments are not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
Editorial acceptance question: assess each supported MR sequence, manual corrections and failed segmentations locally; no vendor monitoring capability is verified.
Vendor product-family context
Phantomics identifies Myomics as its cardiac MRI analysis solution and describes use in domestic and international hospitals; official manufacturer contact is available for configuration requests.
product family · checked 2026-09-05
Official Korean manufacturer page reviewed. Its family deployment narrative does not specify the K241922 release or establish current interfaces, security or clinical performance.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Evidence summary
Exact FDA technical validation is available. Stored cardiac-MR publications require full version review before application to K241922; one unrelated myosin paper is excluded.
Reviewed exact-submission evidence reports segmentation overlap, not a disease-detection sensitivity.
Reported specificity
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-05
A disease-detection specificity for this release was not established in the reviewed sources.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K241922 Myomics bench and AI-module validation
DesignManufacturer bench comparison with Myomics Q/cvi42 Auto and held-out testing of seven segmentation modules
Population728 module-level anonymized test cases across MR vendors; module denominators 92, 91, 109, 90, 77, 192 and 77
Scopeexact submission
Tested versionMyomics configuration submitted in K241922; numerical release unspecified
Samplen=728
IndependenceSponsor or vendor study
K241922
Sample size is the summed module-case count, not confirmed unique patients. All modules reportedly exceeded mean Dice 0.7; detailed estimates, confidence intervals and reference-annotation methods were not established.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
No exact license amount, unit, term or implementation/support costs were established from the reviewed FDA and manufacturer material.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-05
Applicable CMS policy content has not been reviewed. Underlying cardiac MRI billing is not assigned to Myomics.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: Current data flow, access controls, retention, hosting and dated scoped security evidence remain unestablished.
Verify training: The FDA specifies experienced cardiovascular-MR users, but vendor onboarding, competency and support commitments are not established.
Verify pricing and total cost: No exact license amount, unit, term or implementation/support costs were established from the reviewed FDA and manufacturer material.
Verify reimbursement and coding relevance: Applicable CMS policy content has not been reviewed. Underlying cardiac MRI billing is not assigned to Myomics.
Verify local validation and lifecycle monitoring: Editorial acceptance question: assess each supported MR sequence, manual corrections and failed segmentations locally; no vendor monitoring capability is verified.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-05Last searched
21Fields reviewed
11Source classes checked
3Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
All three stored titles/dates screened. PMID 33053464 concerns myosin VI and is unrelated. PMIDs 36447413 and 39841643 are relevant cardiac-MR leads, but metadata alone does not establish K241922 version linkage; neither is promoted. Live PMID 36447413 retrieval returned HTTP 429. No stored trials. The current discovery snapshot contains 3 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, literature index, trial registry, vendor product page, stored candidate metadata, stored recall candidates, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history7 sources - 3 history items
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