510(k) · Cleared
ClearedAcclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
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 20, 2025 as substantially equivalent to K192879 (Edan Instruments, Inc., 2020) after a 27-day review. Its family tree reaches back 27 generations to 1995.
- Decided
- Feb 20, 2025
- Review
- 27 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 27 generations to K935595 (1995). 222 ancestors in all, the oldest K852159 (1985). No later device cites it as a predicate yet.
- Root · 27 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 23 generations between
- 3 generations backK171824 Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic…Edan Instruments, Inc. · 2017
- 2 generations backK180862 Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic…Edan Instruments, Inc. · 2018
- 1 generation backK192879 Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series…Edan Instruments, Inc. · 2020
- This deviceK250214 Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix…Edan Instruments, Inc. · 2025
Show all 27 generations
- Root · 27 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 26 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 25 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 24 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 23 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 22 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 21 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 20 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 19 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 18 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 17 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 16 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 15 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 14 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 13 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 12 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 11 generations backK101041 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 10 generations backK103583 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 9 generations backK113647 DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2011
- 8 generations backK121010 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 7 generations backK131690 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- 6 generations backK141010 M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
- 5 generations backK150080 DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- 4 generations backK162055 Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2017
- 3 generations backK171824 Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic…Edan Instruments, Inc. · 2017
- 2 generations backK180862 Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic…Edan Instruments, Inc. · 2018
- 1 generation backK192879 Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series…Edan Instruments, Inc. · 2020
- This deviceK250214 Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix…Edan Instruments, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −26 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −25 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −24 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −23 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −22 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −21 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −20 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −19 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −18 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −17 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −16 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −15 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −14 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −13 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −12 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −11 | K101041 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −10 | K103583 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −9 | K113647 | DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011 | — |
| −8 | K121010 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| −7 | K131690 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| −6 | K141010 | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014 | — |
| −5 | K150080 | DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| −4 | K162055 | Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017 | — |
| −3 | K171824 | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound… | Edan Instruments, Inc. | 2017 | — |
| −2 | K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound… | Edan Instruments, Inc. | 2018 | — |
| −1 | K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic… | Edan Instruments, Inc. | 2020 | — |
| 0 (this device) | K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7… | Edan Instruments, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 8 | 0 |
| 1998 | 3 | 0 |
| 1999 | 10 | 0 |
| 2000 | 9 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 15 | 0 |
| 2006 | 13 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 10 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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 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? (1)
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 |
|---|---|---|---|
| * | K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Summary page 5…1) Edan Instruments, Inc., Acclarix AX8 Series Diagnostic Ultrasound System/Acclarix LX9 Series Diagnostic Ultrasound System, K192879 (Predicate) 2) Shenzhen Mindray Bio-Medical Electronics Co., Ltd.,… | 2020 |
| † | K210699 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona… | 2021 |
| † | K230066 | Carnation series Diagnostic Ultrasound System | 2023 |
| † | K212900 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 54 of the 222 ancestors have a recall of any class.
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. 2025, 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 Acclarix AX8 Series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics. The Acclarix AX8 Series Diagnostic Ultrasound System clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural and Trans-esophageal Cardiac. The…
Read the full statement (158 words)
The Acclarix AX8 Series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics.
The Acclarix AX8 Series Diagnostic Ultrasound System clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural and Trans-esophageal Cardiac.
The Modes of Operation for Acclarix AX8 Series include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.
The Acclarix AX9 Series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics.
The Acclarix AX9 Series Diagnostic Ultrasound System clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural and Trans-esophageal Cardiac.
The Modes of Operation for Acclarix AX9 Series include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250214: Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250214
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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