510(k) · Cleared
ClearedUltrasound System SONIMAGE MX1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Feb 8, 2018 as substantially equivalent to K162065 (Konica Minolta, Inc., 2016) after a 28-day review. Its family tree reaches back 17 generations to 1995. 1 later device descends from it.
- Decided
- Feb 8, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K935595 (1995). 130 ancestors in all, the oldest K894632 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations between
- 3 generations backK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013
- 2 generations backK142368 Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015 · Recalled
- 1 generation backK162065 Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2016 · Recalled
- This deviceK180084 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK220993 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2022
Show all 17 generations
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 15 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 14 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 13 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 12 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 8 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 7 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
- 5 generations backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 4 generations backK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- 3 generations backK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013
- 2 generations backK142368 Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015 · Recalled
- 1 generation backK162065 Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2016 · Recalled
- This deviceK180084 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −16 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −15 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −14 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −13 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −12 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −11 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −8 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −7 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K081148 | Siemens Acuson 2000 Ultrasound System with Abvs Transducer | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008 | 3 |
| −5 | K111674 | Acuson | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −4 | K121138 | Acuson S3000 Diagnostic Ultrasound System | Siemens Medical Solution | 2012 | — |
| −3 | K130881 | Acuson S2000 and S3000 | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −2 | K142368 | Noblus Diagnostic Ultrasound Scanner | Hitachi Aloka Medical, Ltd. | 2015 | 1 |
| −1 | K162065 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2016 | 2 |
| 0 (this device) | K180084 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2018 | — |
| +1 | K220993 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 11 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 12 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K162065 | Ultrasound System SONIMAGE HS1Summary page 9…iagnostic Ultrasound Transducer (21 CFR 892.1570) Classification Number(s): 90-IYN; 90-IYO; 90-ITX Regulatory Class: Class II Predicate Device(s): K162065 – Ultrasound System SONIMAGE HS1, Konica Minolta, Inc. Device Description: The Ultrasound System… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220993 | Ultrasound System SONIMAGE MX1 | 2022 | 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 23 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 36 of the 130 ancestors have a recall of any class.
- Of its descendants, K220993 (Konica Minolta, Inc., 2022) has gone furthest, with 0 descendants of its own.
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. 2018, 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 Ultrasound System SONIMAGE MX1 and its transducers are products designed to collect ultrasonic image
data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to
visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image
display, Doppler display and/or Doppler sound, offers a procedure applied to the human body for medical
diagnosis or examination. The range of intended clinical applications is same as other conventional ultrasound
imaging systems for general purpose, such as small parts, abdomen, musculoskeletal, and peripheral vascular.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180084: Ultrasound System SONIMAGE MX1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180084
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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