510(k) · Cleared
Recalled · Class II · 2018ACUSON SC2000 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions Inc. Ultrasound Group · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 6, 2016 as substantially equivalent to K142628 (Siemens Medi Cal Solutions, Inc., 2014) after a 29-day review. Its family tree reaches back 20 generations to 1995. 48 later devices descend from it. It has been recalled once.
- Decided
- Sep 6, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 20 generations to K935595 (1995). 147 ancestors in all, the oldest K863700 (1987). 48 later devices descend from it, 2 citing it directly.
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations between
- 3 generations backK130754 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2013
- 2 generations backK132654 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro · 2013
- 1 generation backK142628 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2014
- This deviceK162221 ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group · 2016
- Descendant · cites it directly · 45 of its ownK170315 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 28 of its ownK180067 ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- Descendant · cites it directly · 27 of its ownK163396 ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 3 generations on · 26 of its ownK193257 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · 4 generations on · 25 of its ownK200707 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
Show all 20 generations
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 18 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 17 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 16 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 15 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 14 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 13 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 11 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 10 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 9 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 8 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 7 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 6 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 5 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 4 generations backK123622 AcusonSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 3 generations backK130754 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2013
- 2 generations backK132654 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro · 2013
- 1 generation backK142628 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2014
- This deviceK162221 ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group · 2016
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2017 · cites it directly45descendants
- K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on28descendants
- K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017 · cites it directly27descendants
- K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on26descendants
- K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −19 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −18 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −17 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −16 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −15 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −14 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −13 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −11 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −10 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −9 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −8 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −7 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −6 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −5 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −4 | K123622 | Acuson | Siemens Medical Solutions USA, Inc. | 2012 | 13 |
| −3 | K130754 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2013 | — |
| −2 | K132654 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | — |
| −1 | K142628 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2014 | — |
| 0 (this device) | K162221 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions Inc. Ultrasound Group | 2016 | — |
| +1 | K170315 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2017 | 1 |
| +2 | K180067 | ACUSON X800 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +1 | K163396 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +3 | K193257 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| +4 | K200707 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 9 | 0 |
| 2003 | 10 | 0 |
| 2004 | 15 | 0 |
| 2005 | 11 | 0 |
| 2006 | 8 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 9 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K142628 | Acuson SC2000 Diagnostic Ultrasound SystemSummary page 5…r P P P P P P P* P (Abdominal Vascular) N=new indication. P = Previously Cleared in 510(k) K142628 Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+C… | 2014 |
What descends from it? (48)
See all 482 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 |
|---|---|---|---|---|
| Jan 26, 2018 | Class II | Z-1065-2018 | Under Investigation by firm | The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 40 of the 147 ancestors have a recall of any class.
- Of its descendants, K170315 (Siemens Medi Cal Solutions, Inc., 2017) has gone furthest, with 45 descendants of its own.
- 1 other device also cites its predicate K142628.
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. 2016, 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 SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used…
Read the full statement (558 words)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures 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 typical examinations performed using the SC2000 Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.
Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
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/K162221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162221: ACUSON SC2000 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/K162221
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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