510(k) · Cleared
ClearedAmcad-UT Detection Model 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin & Associates, LLC · LLZ System, Image Processing, Radiological
Cleared on Oct 3, 2013 as substantially equivalent to K021966 (Advanced Technology Laboratories, Inc., 2002) and 2 other predicates after a 409-day review. Its family tree reaches back 6 generations to 1991. 69 later devices descend from it.
- Decided
- Oct 3, 2013
- Review
- 409 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K913770 (1991). 24 ancestors in all. 69 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 2 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 1 generation backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- This deviceK122536 Amcad-UT Detection Model 2.0Lin & Associates, LLC · 2013
- Descendant · cites it directly · 64 of its ownK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- Descendant · 2 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 · 2 generations on · 42 of its ownK171070 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 3 generations on · 39 of its ownK173204 RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · cites it directly64descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 2 generations on58descendants
- K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 2 generations on50descendants
- K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 2 generations on42descendants
- K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 3 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −2 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −1 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| 0 (this device) | K122536 | Amcad-UT Detection Model 2.0 | Lin & Associates, LLC | 2013 | — |
| +1 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| +2 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +2 | K171048 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +2 | K171070 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +3 | K173204 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 10 | 0 |
| 2019 | 10 | 0 |
| 2020 | 6 | 0 |
| 2021 | 9 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (3)
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 2…tantially equivalent to the devices listed below: Model: Q LAB Software Manufacturer: Philips Medical System Company 510(k) Number: K021966, cleared on July 2, 2002 Model: B-CAD System, Version 1.0 Manufacturer: Medipattem Corporation 510(k… | 2002 |
| * | K050846 | B-Cad System, Version 1.0Summary page 2…ber: K021966, cleared on July 2, 2002 Model: B-CAD System, Version 1.0 Manufacturer: Medipattem Corporation 510(k) Number: K050846, cleared on May 26, 2005 Model: ColonCAD API Manufacturer: Medicsight PLC 510(k) Number: K0… | 2005 |
| * | K083423 | Coloncad Api 3.1Summary page 2…orporation 510(k) Number: K050846, cleared on May 26, 2005 Model: ColonCAD API Manufacturer: Medicsight PLC 510(k) Number: K083423, cleared on May 17, 2011 5.4 Device Description AmCAD-UTs Detection 2.0 is a Windows-based computer-assisted detection (CADe)… | 2011 |
What descends from it? (69)
See all 692 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 22 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K162094 (Samsung Medison Co., Ltd., 2016) has gone furthest, with 64 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. 2013, this device’s year, is highlighted.
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?
AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images of user-selected regions of interest (ROI). After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on Philips HDI5000 images of discrete thyroid nodules larger than 1cm, for which a biopsy has been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5-12MHz multi-frequency probe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122536: Amcad-UT Detection Model 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122536
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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