510(k) · Cleared
ClearedLogicscan 64 Logicscan 128
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telemed · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 26, 2012 as substantially equivalent to K100186 (Medison Co., Ltd., 2010) and 1 other predicate after a 90-day review. Its family tree reaches back 14 generations to 1993. 4 later devices descend from it.
- Decided
- Jan 26, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K924432 (1993). 26 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 10 generations between
- 3 generations backK093714 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 2 generations backK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 1 generation backK112646 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- This deviceK113184 Logicscan 64 Logicscan 128Telemed · 2012
- Descendant · cites it directly · 2 of its ownK163121 SmartUs EXT-1M/3MTelemed · 2017
- Descendant · 2 generations on · 0 of its ownK211248 ArtUsTelemed · 2022
- Descendant · 2 generations on · 0 of its ownK181124 Acessa ProVu SystemAcessa Health, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK173486 NTU-USB Ultrasound USB BoxNational Taiwan University · 2018
Show all 14 generations
- Root · 14 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 13 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 12 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 11 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 10 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 9 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 8 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 7 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 6 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 5 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 4 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 3 generations backK093714 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 2 generations backK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 1 generation backK112646 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- This deviceK113184 Logicscan 64 Logicscan 128Telemed · 2012
Most influential descendants
Showing 4 of 4 · See all- K163121SmartUs EXT-1M/3MTelemed · 2017 · cites it directly2descendants
- K211248ArtUsTelemed · 2022 · 2 generations on0descendants
- K181124Acessa ProVu SystemAcessa Health, Inc. · 2018 · 2 generations on0descendants
- K173486NTU-USB Ultrasound USB BoxNational Taiwan University · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −13 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −12 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −11 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −10 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −9 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −8 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −7 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −6 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −5 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −4 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −3 | K093714 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −2 | K102065 | Sonoace R7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −1 | K112646 | Sonoace R7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| 0 (this device) | K113184 | Logicscan 64 Logicscan 128 | Telemed | 2012 | — |
| +1 | K163121 | SmartUs EXT-1M/3M | Telemed | 2017 | — |
| +2 | K211248 | ArtUs | Telemed | 2022 | — |
| +2 | K181124 | Acessa ProVu System | Acessa Health, Inc. | 2018 | — |
| +1 | K173486 | NTU-USB Ultrasound USB Box | National Taiwan University | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K100186 | Mysono U5 Diagnostic Ultrasound SystemSummary page 1…Regulatory Class 11 Predicate Device SAMSUNG MEDISON CO., LTD MySono U5 Diagnostic Ultrasound System K100186 SonoAce R7 Diagnostic Ultrasound System Ki112646 3. Performance Standards The LogicSca… | 2010 |
| * | K112646 | Sonoace R7 Diagnostic Ultrasound SystemSummary page 1…CO., LTD MySono U5 Diagnostic Ultrasound System K100186 SonoAce R7 Diagnostic Ultrasound System Ki112646 3. Performance Standards The LogicScan family has been designed to meet the following: Safety and EMC Reqjuirements for… | 2011 |
What descends from it? (4)
2 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 19 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K163121 (Telemed, 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K100186.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The LogicScan 64 ILogicScan 128 systems and transducers are intended for
diagnostic ultrasound imaging and fluid analysis of the human body.
The applications are:
cardiac (adult), fetal, abdominal, pediatric, small organ, transrectal, neonatal cephalic,
peripheral vessel and musculo-skeletal (conventional and superficial).
It is possible to provide diagnostic information outside of an imaging lab, including at
the bedside systems, for navigated medical application, in operating rooms/critical
care units.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113184: Logicscan 64 Logicscan 128.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113184
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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