510(k) · Cleared
ClearedAccent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Confirma, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 15, 2002 after a 78-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Jan 15, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK013574 AccentConfirma, Inc. · 2002
- Descendant · cites it directly · 17 of its ownK041286 Dynacad V1.0Mri Devices Corp. · 2004
- Descendant · 2 generations on · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- Descendant · 3 generations on · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 4 of its ownK170195 QuantXQuantitative Insights, Inc. · 2017
- Descendant · 4 generations on · 3 of its ownK210670 BU-CADTaihao Medical, Inc. · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K041286Dynacad V1.0Mri Devices Corp. · 2004 · cites it directly17descendants
- K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · 2 generations on9descendants
- K092954Cadstream Version 5Confirma, Inc. · 2009 · 3 generations on8descendants
- K170195QuantXQuantitative Insights, Inc. · 2017 · 3 generations on4descendants
- K210670BU-CADTaihao Medical, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013574 | Accent | Confirma, Inc. | 2002 | — |
| +1 | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | — |
| +2 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| +3 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| +3 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| +4 | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 4 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | — | Vital Images Vitrea Named without a submission number | |
| * | — | Acculmage Image Display Software Named without a submission number | |
| * | — | Siemens BOLD MRI Named without a submission number | |
| * | — | Voxar Plug n’ View 3D Named without a submission number |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041286 | Dynacad V1.0 | 2004 | 17 |
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, K041286 (Mri Devices Corp., 2004) has gone furthest, with 17 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 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?
ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.
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/K013574 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013574: Accent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013574
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026