510(k) · Cleared
ClearedAcuson SC2000 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. Ultrasound Gro · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Sep 26, 2013 as substantially equivalent to K072365 (Siemens Medical Solutions USA, Inc., Ultrasound DI, 2007) and 6 other predicates after a 31-day review. Its family tree reaches back 18 generations to 1995. 53 later devices descend from it.
- Decided
- Sep 26, 2013
- Review
- 31 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 18 generations to K935595 (1995). 145 ancestors in all, the oldest K863700 (1987). 53 later devices descend from it, 3 citing it directly.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 2 generations backK123622 AcusonSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 1 generation backK130754 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2013
- This deviceK132654 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro · 2013
- Descendant · cites it directly · 50 of its ownK142628 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2014
- Descendant · 2 generations on · 48 of its ownK162221 ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group · 2016 · Recalled
- Descendant · 3 generations on · 45 of its ownK170315 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 28 of its ownK180067 ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 3 generations on · 27 of its ownK163396 ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017
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 backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 6 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 5 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 4 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 3 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 2 generations backK123622 AcusonSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 1 generation backK130754 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2013
- This deviceK132654 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro · 2013
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2014 · cites it directly50descendants
- K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group · 2016 · 2 generations on48descendants
- K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2017 · 3 generations on45descendants
- K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018 · 4 generations on28descendants
- K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017 · 3 generations on27descendants
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 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −6 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −5 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −4 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −3 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −2 | K123622 | Acuson | Siemens Medical Solutions USA, Inc. | 2012 | 13 |
| −1 | K130754 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +2 | K162221 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions Inc. Ultrasound Group | 2016 | 1 |
| +3 | K170315 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2017 | 1 |
| +4 | K180067 | ACUSON X800 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +3 | K163396 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2017 | — |
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 |
|---|---|---|
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K072365 | Sequoia Plus Diagnostic Ultrasound SystemSummary page 1…J A. Legally Marketed Predicate Devices The Acuson SC2000 Ultrasound System in this 510k is a modification to SC2000 Diagnostic Ultrasound System previously cleared in K072365, K102017, K1 13179, K123622 and K130754. B. Device Description: The SC2000 Diagnostic Ultrasound System is a multi-purpose mobile… | 2007 |
| * | K072786 | Acuson S2000 Ultrasound SystemSummary page 3…510(k) Submission D. Substantial Equivalence The submission device is a modification to SC2000 M Diagnostic Ultrasound System previously cleared in K072365, K072786, K102017, K113179, K123622 and K130754 with regard to both intended use and technological characteristics.… | 2007 |
| * | K102017 | SC2000 Diagnostic Ultrasound SystemSummary page 1…gally Marketed Predicate Devices The Acuson SC2000 Ultrasound System in this 510k is a modification to SC2000 Diagnostic Ultrasound System previously cleared in K072365, K102017, K1 13179, K123622 and K130754. B. Device Description: The SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, softwar… | 2010 |
| * | K113179 | Acuson SC2000 Diagnostic Ultrasound SystemSummary page 1…keted Predicate Devices The Acuson SC2000 Ultrasound System in this 510k is a modification to SC2000 Diagnostic Ultrasound System previously cleared in K072365, K102017, K1 13179, K123622 and K130754. B. Device Description: The SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, software controll… | 2011 |
| * | K123622 | AcusonSummary page 1…icate Devices The Acuson SC2000 Ultrasound System in this 510k is a modification to SC2000 Diagnostic Ultrasound System previously cleared in K072365, K102017, K1 13179, K123622 and K130754. B. Device Description: The SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagno… | 2012 |
| * | K130754 | Acuson SC2000 Diagnostic Ultrasound SystemSummary page 1…s The Acuson SC2000 Ultrasound System in this 510k is a modification to SC2000 Diagnostic Ultrasound System previously cleared in K072365, K102017, K1 13179, K123622 and K130754. B. Device Description: The SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultraso… | 2013 |
| * | K111674 | AcusonSummary page 5…e device description above, the modified device has substantially equivalent indications for use and technological characteristics as the predicate devices ACUSON S2000 (K1 11674, 072786) and ACUSON SC2000 (K113179) Differences There are no differences for the new transducer (6C1 HD) and feature (Clarify V… | 2011 |
What descends from it? (53)
See all 533 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 18 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 40 of the 145 ancestors have a recall of any class.
- Of its descendants, K142628 (Siemens Medi Cal Solutions, Inc., 2014) has gone furthest, with 50 descendants of its own.
- 5 other devices also cite its predicate K072365.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal lntraoperative. lntraoperative, 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…
Read the full statement (653 words)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and
Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal
lntraoperative. lntraoperative, 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
20 (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (GPO), Pulsed Wave (PR 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 transmits ultrasound energy from either a transthoracic or transesophageal approach in
adult and pediatric patients: and from a transthoracic approach in neonatal and fetal cardiac patients
creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPO). Pulsed Wave (PVY)
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 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, 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 (a),
Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWVD), 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.
lntraoperatlve 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.
Transcranlal Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 20 (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 as stated in the FDA summary.
https://510kreport.com/device/K132654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132654: 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/K132654
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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