510(k) · Cleared
ClearedACUSON P500 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 Jan 4, 2017 as substantially equivalent to K150050 (Siemens Medical Solutions USA, Inc., 2015) and 5 other predicates after a 30-day review. Its family tree reaches back 22 generations to 1995. 27 later devices descend from it.
- Decided
- Jan 4, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 22 generations to K935595 (1995). 213 ancestors in all, the oldest K863700 (1987). 27 later devices descend from it, 4 citing it directly.
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations between
- 3 generations backK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 2 generations backK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- 1 generation backK162417 Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- This deviceK163396 ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017
- Descendant · cites it directly · 25 of its ownK180039 ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 23 of its ownK191922 ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2019
- Descendant · 3 generations on · 15 of its ownK210743 ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 14 of its ownK201130 ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · 4 generations on · 6 of its ownK221500 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2022
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 backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 18 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 17 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 16 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 15 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 14 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 13 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 12 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 11 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 10 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 9 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 8 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 7 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 6 generations backK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 5 generations backK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- 4 generations backK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
- 3 generations backK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 2 generations backK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- 1 generation backK162417 Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- This deviceK163396 ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018 · cites it directly25descendants
- K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2019 · 2 generations on23descendants
- K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021 · 3 generations on15descendants
- K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on14descendants
- K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2022 · 4 generations on6descendants
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 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −18 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −17 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −16 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −15 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −14 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −13 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −12 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −11 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −10 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −9 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −8 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −7 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −6 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| −5 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| −4 | K140959 | Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −3 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | 1 |
| −2 | K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2015 | — |
| −1 | K162417 | Acuson Freestyle Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| 0 (this device) | K163396 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +1 | K180039 | ACUSON P600 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K191922 | ACUSON P200 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +3 | K210743 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021 | 3 |
| +2 | K201130 | ACUSON Juniper Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 4 |
| +4 | K221500 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2022 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (6)
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 |
|---|---|---|---|
| * | K150050 | ACUSON P500 Diagnostic Ultrasound SystemSummary page 5…Other (Specify) Peripheral vessel Peripheral (Note 5) Vessel Other (Specify) N = new indication; P = previously cleared K150050 Note 1 For example: breast, testes, thyroid, prostate, etc. Note 6 Stress Echo Note 2 Dynamic TCE Techn… | 2015 |
| * | K141846 | Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSummary page 10…Other (Specify) Peripheral vessel Peripheral (Note 5) Vessel Other (Specify) N = new indication; P = previously cleared K141846 Note 1 For example: breast, testes, thyroid, prostate, etc. Note 6 Stress Echo Note 2 Dynamic TCE Techno… | 2014 |
| * | K162221 | ACUSON SC2000 Diagnostic Ultrasound SystemSummary page 21…rasound System Ultrasound Division 510(k) Submission ACUSON P500 (K150050), ACUSON X700 (K141846), ACUSON SC2000 (K162221), ACUSON NX2 (K161787), ACUSON Freestyle (K162417) and Vivid i&q (K121062) B. Device Description: The ACUSON P500TM Ultrasound… | 2016 |
| * | K161787 | ACUSON NX2 Diagnostic Ultrasound SystemsSummary page 11…ecify) Peripheral vessel Peripheral (Note 5) Vessel Other (Specify) N = new indication; P = previously cleared by K141846, K161787 Note 1 For example: breast, testes, thyroid, prostate, etc. Note 6 Stress Echo Note 2 Dynamic TCE Techno… | 2016 |
| * | K162417 | Acuson Freestyle Ultrasound SystemSummary page 21…510(k) Submission ACUSON P500 (K150050), ACUSON X700 (K141846), ACUSON SC2000 (K162221), ACUSON NX2 (K161787), ACUSON Freestyle (K162417) and Vivid i&q (K121062) B. Device Description: The ACUSON P500TM Ultrasound System is a multi-purpose mobile, software contro… | 2016 |
| * | K121062 | Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound SystemSummary page 21…510(k) Submission ACUSON P500 (K150050), ACUSON X700 (K141846), ACUSON SC2000 (K162221), ACUSON NX2 (K161787), ACUSON Freestyle (K162417) and Vivid i&q (K121062) B. Device Description: The ACUSON P500TM Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultraso… | 2012 |
What descends from it? (27)
See all 274 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)
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 22 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 58 of the 213 ancestors have a recall of any class.
- Of its descendants, K180039 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 25 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. 2017, 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 P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic, Neonatal, Cardiac, IntraCardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications. The system also provides the ability to measure…
Read the full statement (232 words)
The ACUSON P500 ultrasound imaging system is intended for the following applications:
Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic, Neonatal, Cardiac, IntraCardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.
The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
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 should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease 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 Imaging."
The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
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/K163396 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163396: ACUSON P500 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163396
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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