510(k) · Cleared
ClearedM'ath STD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligence IN Medical Technologies · LLZ System, Image Processing, Radiological
Cleared on Jul 30, 2004 as substantially equivalent to K021966 (Advanced Technology Laboratories, Inc., 2002) and 1 other predicate after a 136-day review. Its family tree reaches back 2 generations to 2002. 122 later devices descend from it.
- Decided
- Jul 30, 2004
- Review
- 136 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021966 (2002). 122 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK021966 Q Lab SoftwareAdvanced Technology Laboratories, Inc. · 2002
- 1 generation backK030223 SonocalcSonometric Health, LLC · 2003 · Recalled
- This deviceK040686 M'ath STDIntelligence IN Medical Technologies · 2004
- Descendant · cites it directly · 98 of its ownK121223 Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc. · 2012
- Descendant · 2 generations on · 64 of its ownK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- Descendant · 3 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 2 generations on · 50 of its ownK171048 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 3 generations on · 42 of its ownK171070 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 122 · See all- K121223Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc. · 2012 · cites it directly98descendants
- K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · 2 generations on64descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on58descendants
- K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 2 generations on50descendants
- K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021966 | Q Lab Software | Advanced Technology Laboratories, Inc. | 2002 | — |
| −1 | K030223 | Sonocalc | Sonometric Health, LLC | 2003 | 1 |
| 0 (this device) | K040686 | M'ath STD | Intelligence IN Medical Technologies | 2004 | — |
| +1 | K121223 | Qlab with FHN and VPQ Plug-in | Philips Ultrasound, Inc. | 2012 | — |
| +2 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| +3 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +2 | K171048 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +3 | K171070 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 8 | 0 |
| 2018 | 14 | 0 |
| 2019 | 10 | 0 |
| 2020 | 12 | 0 |
| 2021 | 11 | 0 |
| 2022 | 13 | 0 |
| 2023 | 9 | 0 |
| 2024 | 14 | 0 |
| 2025 | 11 | 0 |
| 2026 | 12 | 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? (2)
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 |
|---|---|---|---|
| * | K021966 | Q Lab SoftwareSummary page 1…nd Medical Image Measurement Software Classification Name: 892.2050-System, Image processing, Radiological. 3. Predicate substantially equivalent devices: - K021966, 0 Lab Software, Advanced Technology Laboratories, Inc. (dba Philips Ultrasound); -- - K030223, Sonocalc, SonoMetric Hea… | 2002 |
| * | K030223 | SonocalcSummary page 1…gical. 3. Predicate substantially equivalent devices: - K021966, 0 Lab Software, Advanced Technology Laboratories, Inc. (dba Philips Ultrasound); -- - K030223, Sonocalc, SonoMetric Health, LLC. 4. Device description: MAth®Std is a software running on a stand alone computer under Micros… | 2003 |
What descends from it? (122)
See all 1222 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K121223 (Philips Ultrasound, Inc., 2012) has gone furthest, with 98 descendants of its own.
- 13 other devices also cite its predicate K021966.
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?
M'Ath Std software is a Windows-based application program running on a personal computer that is intended to aid the physician in the organization of patient data relating to the ultrasound images or video acquired during echo-cardiology exams of the cardiovascular system, including the patient's characteristics. Additionally, the software allows the physician to makes measurements to determine the intima-media thickness of the carotoid artery from the acquired images and stores them with the patient file.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040686 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040686: M'ath STD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040686
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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