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. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 23, 2022 as substantially equivalent to K180084 (Konica Minolta, Inc., 2018) after an 80-day review. Its family tree reaches back 18 generations to 1995.
- Decided
- Jun 23, 2022
- Review
- 80 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K935595 (1995). 131 ancestors in all, the oldest K894632 (1989). No later device cites it as a predicate yet.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK142368 Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015 · Recalled
- 2 generations backK162065 Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2016 · Recalled
- 1 generation backK180084 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2018
- This deviceK220993 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2022
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 backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 14 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 9 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 8 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 7 generations backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
- 6 generations backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 5 generations backK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- 4 generations backK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013
- 3 generations backK142368 Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015 · Recalled
- 2 generations backK162065 Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2016 · Recalled
- 1 generation backK180084 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2018
- This deviceK220993 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2022
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 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −14 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −12 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −9 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −8 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −7 | K081148 | Siemens Acuson 2000 Ultrasound System with Abvs Transducer | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008 | 3 |
| −6 | K111674 | Acuson | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −5 | K121138 | Acuson S3000 Diagnostic Ultrasound System | Siemens Medical Solution | 2012 | — |
| −4 | K130881 | Acuson S2000 and S3000 | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −3 | K142368 | Noblus Diagnostic Ultrasound Scanner | Hitachi Aloka Medical, Ltd. | 2015 | 1 |
| −2 | K162065 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2016 | 2 |
| −1 | K180084 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K180084 | Ultrasound System SONIMAGE MX1Summary page 4…Diagnostic Ultrasound Transducer (21 CFR 892.1570) Regulatory Class: Class II Product Code(s): IYN, IYO, ITX Predicate Device: K180084 - Ultrasound System SONIMAGE MX1 Reference Device: K182153 - Ultrasound System SONIMAGE HS1 Device Description The Ultra… | 2018 |
| † | K182153 | Ultrasound System SONIMAGE HS1 | 2018 |
| † | K142197 | Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2 | 2014 |
| † | K162065 | Ultrasound System SONIMAGE HS1 | 2016 |
| † | K151060 | Ultrasound System SONIMAGE HS1 | 2015 |
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 27 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 36 of the 131 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. 2022, 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 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…
Read the full statement (137 words)
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, cardiac, and peripheral vascular.
This device is intended for use in healthcare facilities, such as health clinics and hospitals.
Intended user for the device are physician, sonographer, and other trained qualified healthcare professionals.
Modes of operation include B-mode, M-mode, PWD-mode, CWD-mode, Color Doppler-mode, Power Doppler-mode, and their Combined mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220993: 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/K220993
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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