510(k) · Cleared
Recalled · Class II · 2024ACUSON Juniper Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 26, 2020 as substantially equivalent to K180039 (Siemens Medical Solutions USA, Inc., 2018) after a 28-day review. Its family tree reaches back 24 generations to 1995. 14 later devices descend from it. It has been recalled 4 times.
- Decided
- May 26, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 24 generations to K935595 (1995). 218 ancestors in all, the oldest K863700 (1987). 14 later devices descend from it, 3 citing it directly.
- Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations between
- 3 generations backK162417 Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- 2 generations backK163396 ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017
- 1 generation backK180039 ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- This deviceK201130 ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK202683 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000…Siemens Medical Solutions USA, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK221190 ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper…Siemens Medical Solutions USA, Inc. · 2022
- Descendant · 2 generations on · 4 of its ownK211726 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK230207 ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select…Siemens Medical Solutions USA, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK242893 VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited · 2025
Show all 24 generations
- Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 23 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 22 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 21 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 20 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 19 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 18 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 17 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 16 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 15 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 14 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 13 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 12 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 11 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 10 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 9 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 8 generations backK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 7 generations backK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- 6 generations backK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
- 5 generations backK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 4 generations backK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- 3 generations backK162417 Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- 2 generations backK163396 ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017
- 1 generation backK180039 ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- This deviceK201130 ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc. · 2020 · cites it directly6descendants
- K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc. · 2022 · cites it directly4descendants
- K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021 · 2 generations on4descendants
- K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc. · 2023 · 2 generations on3descendants
- K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited · 2025 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −23 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −22 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −21 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −20 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −19 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −18 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −17 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −16 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −15 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −14 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −13 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −12 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −11 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −10 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −9 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −8 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| −7 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| −6 | K140959 | Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −5 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | 1 |
| −4 | K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2015 | — |
| −3 | K162417 | Acuson Freestyle Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| −2 | K163396 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −1 | K180039 | ACUSON P600 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
| 0 (this device) | K201130 | ACUSON Juniper Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +1 | K202683 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic… | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +1 | K221190 | ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select… | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +2 | K211726 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +2 | K230207 | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic… | Siemens Medical Solutions USA, Inc. | 2023 | — |
| +3 | K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 8 | 0 |
| 2001 | 9 | 0 |
| 2002 | 13 | 0 |
| 2003 | 15 | 0 |
| 2004 | 16 | 0 |
| 2005 | 13 | 0 |
| 2006 | 9 | 0 |
| 2007 | 10 | 0 |
| 2008 | 10 | 0 |
| 2009 | 10 | 0 |
| 2010 | 11 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K180039 | ACUSON P600 Diagnostic Ultrasound SystemSummary page 4…P P P P P BCDM (Note 11) N = new indication; P = previously cleared by K180039 Note 1 Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) Note 2… | 2018 |
| † | K191922 | ACUSON P200 Diagnostic Ultrasound System | 2019 |
| † | K141846 | Acuson X700 Ultrasound System, Acuson X600 Ultrasound System | 2014 |
| † | K193257 | ACUSON Sequoia Diagnostic Ultrasound System | 2020 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2024 | Class II | Z-3215-2024 | Software design | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to… |
| Feb 23, 2024 | Class II | Z-1599-2024 | Software design | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer… |
| Jan 19, 2022 | Class II | Z-0748-2022 | Software design | The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk… |
| Jul 12, 2021 | Class II | Z-2471-2021 | Software change control | Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 60 of the 218 ancestors have a recall of any class.
- Of its descendants, K202683 (Siemens Medical Solutions USA, Inc., 2020) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K180039.
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. 2020, 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 ACUSON Juniper ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, Musculoskeletal, and Intraoperative applications using different ultrasound transducers for different applications. The system also…
Read the full statement (215 words)
The ACUSON Juniper ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, Musculoskeletal, and Intraoperative applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in vitro fertilization (IVF), chorionic villus sampling (CVS), and percutancous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.
This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Discase and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."
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/K201130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201130: ACUSON Juniper 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/K201130
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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