510(k) · Cleared
Recalled · Class II · 2017Ultrasound System Sonimage HS 1
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 Oct 8, 2015 as substantially equivalent to K151060 (Konica Minolta, Inc., 2015) and 1 other predicate after a 29-day review. Its family tree reaches back 15 generations to 1989. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 8, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 15 generations to K894632 (1989). 62 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 11 generations between
- 3 generations backK093171 Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C · 2009
- 2 generations backK142197 Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc. · 2014 · Recalled
- 1 generation backK151060 Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2015 · Recalled
- This deviceK152577 Ultrasound System Sonimage HS 1Konica Minolta, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK162065 Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK180084 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK220993 Ultrasound System SONIMAGE MX1Konica Minolta, Inc. · 2022
Show all 15 generations
- Root · 15 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 14 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 13 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 12 generations backK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- 11 generations backK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- 10 generations backK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- 9 generations backK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
- 8 generations backK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled
- 7 generations backK072000 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007
- 6 generations backK081065 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C · 2008
- 5 generations backK082119 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C · 2008
- 4 generations backK091295 Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C · 2009 · Recalled
- 3 generations backK093171 Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C · 2009
- 2 generations backK142197 Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc. · 2014 · Recalled
- 1 generation backK151060 Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2015 · Recalled
- This deviceK152577 Ultrasound System Sonimage HS 1Konica Minolta, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −14 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −13 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −12 | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −11 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| −10 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| −9 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
| −8 | K063130 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 | Toshibamedical Systems Corporation | 2006 | 1 |
| −7 | K072000 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 | Toshiba America Medical Systems, In.C | 2007 | — |
| −6 | K081065 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2 | Toshiba America Medical Systems, In.C | 2008 | — |
| −5 | K082119 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0 | Toshiba America Medical Systems, In.C | 2008 | — |
| −4 | K091295 | Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0 | Toshiba America Medical Systems, In.C | 2009 | 2 |
| −3 | K093171 | Viamo Ssa-640A Version 1.2 | Toshiba America Medical Systems, In.C | 2009 | — |
| −2 | K142197 | Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2 | Konica Minolta, Inc. | 2014 | 2 |
| −1 | K151060 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2015 | 1 |
| 0 (this device) | K152577 | Ultrasound System Sonimage HS 1 | Konica Minolta, Inc. | 2015 | — |
| +1 | K162065 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2016 | 2 |
| +2 | K180084 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2018 | — |
| +3 | K220993 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K151060 | 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): K151060 – Ultrasound System SONIMAGE HS1, Konica Minolta, Inc. K061605 – Nemio XG… | 2015 |
| * | K061605 | Nemio XG, Saa-580ASummary page 9…: Class II Predicate Device(s): K151060 – Ultrasound System SONIMAGE HS1, Konica Minolta, Inc. K061605 – Nemio XG, SSA-580A, Toshiba America Medical Systems, Inc. Modification Description:… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162065 | Ultrasound System SONIMAGE HS1 | 2016 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2017 | Class II | Z-1213-2018 | Device Design | There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result. |
| Apr 24, 2017 | Class II | Z-2769-2017 | Software design | The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 11 of the 62 ancestors have a recall of any class.
- Of its descendants, K162065 (Konica Minolta, Inc., 2016) has gone furthest, with 2 descendants of its own.
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. 2015, 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 HS1 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 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 (soft tissue), peripheral vascular, and Cardiac.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152577: Ultrasound System Sonimage HS 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152577
Report an extraction error
Are you the manufacturer?
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