510(k) · Cleared
ClearedAcclarix AX8 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 31, 2016 as substantially equivalent to K150999 (Edan Instruments, Inc., 2015) and 1 other predicate after a 22-day review. Its family tree reaches back 22 generations to 1995. 9 later devices descend from it.
- Decided
- May 31, 2016
- Review
- 22 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K935595 (1995). 189 ancestors in all, the oldest K852159 (1985). 9 later devices descend from it, 1 citing it directly.
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations between
- 3 generations backK121010 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 2 generations backK131690 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- 1 generation backK150999 Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2015
- This deviceK161300 Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2016
- Descendant · cites it directly · 8 of its ownK162055 Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK171824 Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic…Edan Instruments, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK180862 Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic…Edan Instruments, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK171900 Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2017
- Descendant · 4 generations on · 1 of its ownK192879 Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series…Edan Instruments, Inc. · 2020
Show all 22 generations
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 20 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 19 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 18 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 17 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 16 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 15 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 14 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 13 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 12 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 11 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 10 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 9 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 8 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 7 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 6 generations backK101041 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 5 generations backK103583 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- 4 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
- 3 generations backK121010 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 2 generations backK131690 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- 1 generation backK150999 Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2015
- This deviceK161300 Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2017 · cites it directly8descendants
- K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2017 · 2 generations on7descendants
- K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2018 · 3 generations on3descendants
- K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc. · 2017 · 3 generations on2descendants
- K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc. · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −21 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −20 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −19 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −18 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −17 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −16 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −15 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −14 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −13 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −12 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −11 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −10 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −9 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −8 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −7 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −6 | K101041 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −5 | K103583 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| −4 | 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 | — |
| −3 | K121010 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| −2 | K131690 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| −1 | K150999 | Acclarix Diagnostic Ultrasound System | Edan Instruments, Inc. | 2015 | — |
| 0 (this device) | K161300 | Acclarix AX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2016 | — |
| +1 | K162055 | Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017 | — |
| +2 | K171824 | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound… | Edan Instruments, Inc. | 2017 | — |
| +3 | K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound… | Edan Instruments, Inc. | 2018 | — |
| +3 | K171900 | Acclarix AX4 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017 | — |
| +4 | K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic… | Edan Instruments, Inc. | 2020 | — |
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 | 12 | 0 |
| 2004 | 17 | 0 |
| 2005 | 14 | 0 |
| 2006 | 12 | 0 |
| 2007 | 9 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K150999 | Acclarix Diagnostic Ultrasound SystemSummary page 15…ice is Class II. Notification Class III Certification and Summary 4. Predicate Acclarix AX8 Diagnostic ultrasound system/ K150999/ Shenzhen Edan Device(s): Instruments, Inc. U50 Diagnostic ultrasound sy… | 2015 |
| * | K142511 | U50 Diagnostic Ultrasound SystemSummary page 15…gnostic ultrasound system/ K150999/ Shenzhen Edan Device(s): Instruments, Inc. U50 Diagnostic ultrasound system/ K142511/ Shenzhen Edan Instruments, Inc. 5. Reason for Modification for previous c… | 2015 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162055 | Acclarix LX8 Diagnostic Ultrasound System | 2017 | 8 |
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 21 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 43 of the 189 ancestors have a recall of any class.
- Of its descendants, K162055 (Edan Instruments, Inc., 2017) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K150999.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound
evaluations. Specific clinical applications include:
Abdominal
Gynecology (including endovaginal)
Obstetric
Cardiac
Small parts (Breast, Testes, Thyroid, etc.)
Urology
Musculoskeletal
Peripheral vascular
Intra-operative
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161300: Acclarix AX8 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161300
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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