510(k) Report

510(k) · Cleared

Cleared

Modification to Acuson X150 Ultrasound System

K081121510(k) TraditionalCleared Jun 4, 200844-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions USA, Inc., Ultrasound DI · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jun 4, 2008 as substantially equivalent to K070576 (Siemens Medical Solutions USA, Inc., 2007) after a 44-day review. Its family tree reaches back 1 generation to 2007. 101 later devices descend from it.

Decided
Jun 4, 2008
Review
44 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K070576 (2007). 101 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 4 descendants cleared2009: 1 descendant cleared2015: 3 descendants cleared2014: 7 descendants cleared2018: 6 descendants cleared2013: 4 descendants cleared2016: 5 descendants cleared2017: 8 descendants cleared2019: 6 descendants cleared2021: 7 descendants cleared2025: 9 descendants cleared2020: 11 descendants cleared2022: 9 descendants cleared2024: 9 descendants cleared2023: 7 descendants cleared2026: 5 descendants clearedK070576 · Acuson X150 Ultrasound System · Siemens Medical Solutions USA, Inc. · 200720052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 7 descendants4 generations forward: 10 descendants5 generations forward: 13 descendants6 generations forward: 14 descendants7 generations forward: 10 descendants8 generations forward: 8 descendants9 generations forward: 8 descendants10 generations forward: 6 descendants11 generations forward: 10 descendants12 generations forward: 5 descendants13 generations forward: 2 descendants14 generations forward: 2 descendants15 generations forward: 1 descendant16 generations forward: 2 descendants K070576 · Acuson X150 Ultrasound System · Siemens Medical Solutions USA, Inc. · 20070+5+10+15
  1. Root · 1 generation backK070576 Acuson X150 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
  2. This deviceK081121 Modification to Acuson X150 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
  3. Descendant · cites it directly · 99 of its ownK093531 Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2009
  4. Descendant · 2 generations on · 98 of its ownK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
  5. Descendant · 3 generations on · 96 of its ownK123622 AcusonSiemens Medical Solutions USA, Inc. · 2012 · Recalled
  6. Descendant · 3 generations on · 74 of its ownK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
  7. Descendant · 4 generations on · 73 of its ownK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled

Showing 5 of 101 descendants. See all descendants

Descendants cleared per year

2009: 12012: 42013: 42014: 72015: 32016: 52017: 82018: 62019: 62020: 112021: 72022: 92023: 72024: 92025: 92026: 5
2009high 11 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 101 · See all
  • K093531Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2009 · cites it directly99descendants
  • K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on98descendants
  • K123622AcusonSiemens Medical Solutions USA, Inc. · 2012 · 3 generations on96descendants
  • K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 3 generations on74descendants
  • K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · 4 generations on73descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K070576Acuson X150 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007—
0 (this device)K081121Modification to Acuson X150 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2008—
+1K093531Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2009—
+2K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.2012—
+3K123622AcusonSiemens Medical Solutions USA, Inc.201213
+3K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.20122
+4K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro20133

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201240
201340
201470
201530
201650
201780
201860
201960
2020110
202170
202290
202370
202490
202590
202650
FIG. 1 — Lineage of K081121, 2007–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K070576Acuson X150 Ultrasound System
Summary page 1
…iagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X150 ultrasound system (K070576). B. Device Description: The Siemens ACUSON X150 has been designed to meet the following product safety standards:…
Siemens Medical Solutions USA, Inc.2007—

What descends from it? (101)

See all 101

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093531Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.200999
K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120

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?

  • Its one ancestor has no recall.
  • Of its descendants, K093531 (Siemens Medi Cal Solutions, Inc., 2009) has gone furthest, with 99 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

What is it indicated for?

The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Indications for use as stated in the FDA summary.

More from Siemens Medical Solutions USA, Inc.…

11 FDA decisions under this applicant name. See the company

  • K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI · 2017
  • K113179Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2011
  • K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2011
  • K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 20083 recalls
  • K082142Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 20088 recalls

Recent decisions in IYO

The IYO category page

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https://510kreport.com/device/K081121 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081121: Modification to Acuson X150 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/K081121

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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