510(k) · Cleared
ClearedDiagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 8, 2013 as substantially equivalent to K110999 (Edan Instruments, Inc., 2011) and 3 other predicates after a 114-day review. Its family tree reaches back 18 generations to 1995. 21 later devices descend from it.
- Decided
- Feb 8, 2013
- Review
- 114 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K935595 (1995). 125 ancestors in all, the oldest K852159 (1985). 21 later devices descend from it, 5 citing it directly.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 2 generations backK100830 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 1 generation backK102991 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- This deviceK123249 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2013
- Descendant · cites it directly · 13 of its ownK142511 U50 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2015
- Descendant · cites it directly · 12 of its ownK150999 Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2015
- Descendant · 2 generations on · 9 of its ownK161300 Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2016
- Descendant · 2 generations on · 9 of its ownK160790 Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2016
- Descendant · 3 generations on · 8 of its ownK162055 Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2017
Show all 18 generations
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 16 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 15 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 14 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 12 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 11 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 10 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 9 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 8 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 7 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 6 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 5 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 4 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 3 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 2 generations backK100830 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 1 generation backK102991 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- This deviceK123249 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2015 · cites it directly13descendants
- K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2015 · cites it directly12descendants
- K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2016 · 2 generations on9descendants
- K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2016 · 2 generations on9descendants
- K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2017 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −17 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −16 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −15 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −14 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −12 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −11 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −10 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −9 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −8 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −7 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −6 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −5 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −4 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −3 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −2 | K100830 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −1 | K102991 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| 0 (this device) | K123249 | Diagnostic Ultrasound System | Edan Instruments, Inc. | 2013 | — |
| +1 | K142511 | U50 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2015 | — |
| +1 | K150999 | Acclarix Diagnostic Ultrasound System | Edan Instruments, Inc. | 2015 | — |
| +2 | K161300 | Acclarix AX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2016 | — |
| +2 | K160790 | Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2016 | — |
| +3 | K162055 | Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 10 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K110999 | Digital Ultrasonic Diagnostic Imaging System | 2011 |
| * | K072164 | DC-6 Diagnostic Ultrasound SystemSummary page 1…DUS 60 Digital Ultrasonic Diagnostic Imaging System /Kl 10999/ Device: Edan Instruments, Inc. DC-6 Diagnostic Ultrasound System / K072 164 / Shenzhen Mindray Bio-medical Electronics Co.; Ltd. M5 Diagnostic Ultrasound Syste… | 2007 |
| * | K102991 | M5 Diagnostic Ultrasound SystemSummary page 1…gnostic Ultrasound System / K072 164 / Shenzhen Mindray Bio-medical Electronics Co.; Ltd. M5 Diagnostic Ultrasound System / K102991 / Shenzhen Mindray Bio-medical Electronics Co., Ltd. GE LOGIQ E9 Diagnostic Ultraso… | 2010 |
| * | K082185 | GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Summary page 1…Ultrasound System / K102991 / Shenzhen Mindray Bio-medical Electronics Co., Ltd. GE LOGIQ E9 Diagnostic Ultrasound System! K082 185/ General Electric Co.… | 2008 |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142511 | U50 Diagnostic Ultrasound System | 2015 | 13 |
| K150999 | Acclarix Diagnostic Ultrasound System | 2015 | 12 |
| K131830 | Digital Ultrasonic Diagnostic Imaging System | 2013 | 1 |
| K163688 | Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 | 2017 | 0 |
| K132059 | Diagnostic Ultrasound System | 2013 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 27 of the 125 ancestors have a recall of any class.
- Of its descendants, K142511 (Edan Instruments, Inc., 2015) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K110999.
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. 2013, 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 diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123249 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123249: Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123249
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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