510(k) Report

510(k) · Cleared

Cleared

Sonoline G50 and G60 S Diagnostic Ultrasound Systems

K040060510(k) TraditionalCleared Jan 28, 200415-day reviewClass II21 CFR 892.1550

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. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jan 28, 2004 as substantially equivalent to K020353 (Siemens Medical Systems, Inc., 2002) and 3 other predicates after a 15-day review. Its family tree reaches back 4 generations to 1995. 2 of the 969 devices in its family, counting itself, have a Class I recall. 950 later devices descend from it.

Decided
Jan 28, 2004
Review
15 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K935595 (1995). 18 ancestors in all, the oldest K921148 (1992). 950 later devices descend from it, 6 citing it directly. 2 of the 969 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 4 other ancestors1995: 3 other ancestors1999: 3 other ancestors1997: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestor2004: 2 descendants cleared2005: 7 descendants cleared2006: 7 descendants cleared2012: 32 descendants cleared2007: 9 descendants cleared2013: 41 descendants cleared2010: 18 descendants cleared2008: 9 descendants cleared2009: 14 descendants cleared2015: 53 descendants cleared2011: 26 descendants cleared2017: 76 descendants cleared2018: 65 descendants cleared2014: 45 descendants cleared2016: 59 descendants cleared2019: 49 descendants cleared2024: 65 descendants cleared2020: 73 descendants cleared2023: 57 descendants cleared2021: 53 descendants cleared2025: 79 descendants cleared, 2 with a Class I recall22022: 57 descendants cleared2026: 54 descendants clearedK935595 · Acuson Model 3001 · Acuson Corp. · 1995K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K022567 · Sequoia Signature II Diagnostic Ultrasound System · Acuson Corp. · 2002K032111 · Acuson CV70 Cardiovascular System · Siemens Medical Solutions USA, Inc. · 2003 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 5 other ancestors4 generations back: 4 other ancestors 1 generation forward: 6 descendants2 generations forward: 13 descendants3 generations forward: 18 descendants4 generations forward: 49 descendants5 generations forward: 99 descendants6 generations forward: 123 descendants7 generations forward: 115 descendants8 generations forward: 130 descendants9 generations forward: 131 descendants10 generations forward: 93 descendants, 2 with a Class I recall211 generations forward: 64 descendants12 generations forward: 45 descendants13 generations forward: 34 descendants14 generations forward: 20 descendants15 generations forward: 8 descendants16 generations forward: 2 descendants K032111 · Acuson CV70 Cardiovascular System · Siemens Medical Solutions USA, Inc. · 2003 · recalledK022567 · Sequoia Signature II Diagnostic Ultrasound System · Acuson Corp. · 2002K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K935595 · Acuson Model 3001 · Acuson Corp. · 19950+5+10+15
  1. Root · 4 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 3 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
  3. 2 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  4. 1 generation backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
  5. This deviceK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
  6. Descendant · cites it directly · 927 of its ownK043016 Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
  7. Descendant · cites it directly · 926 of its ownK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  8. Descendant · cites it directly · 921 of its ownK050034 Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  9. Descendant · cites it directly · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  10. Descendant · 2 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006

Showing 5 of 950 descendants. See all descendants

Descendants cleared per year

2004: 22005: 72006: 72007: 92008: 92009: 142010: 182011: 262012: 322013: 412014: 452015: 532016: 592017: 762018: 652019: 492020: 732021: 532022: 572023: 572024: 652025: 792026: 54
2004high 79 (2025) · low 2 (2004)2026

Class I recalls in this family

  • K242670 Lumify Diagnostic Ultrasound System10 generations on · 2025
  • K242519 Lumify Diagnostic Ultrasound System10 generations on · 2025

Most influential descendants

Showing 5 of 950 · See all
  • K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · cites it directly927descendants
  • K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · cites it directly926descendants
  • K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · cites it directly921descendants
  • K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · cites it directly806descendants
  • K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on802descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K935595Acuson Model 3001Acuson Corp.1995—
−3K973767Harmonic Imaging with ContrastAcuson Corp.1997—
−2K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.2002—
−1K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20031
0 (this device)K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004—
+1K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004—
+1K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20051
+1K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20051
+1K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20051
+2K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410
199530
199710
199930
200040
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200570
200670
200790
200890
2009140
2010180
2011260
2012320
2013410
2014450
2015530
2016590
2017760
2018650
2019490
2020730
2021530
2022570
2023570
2024650
2025792
2026540
FIG. 1 — Lineage of K040060, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

2 devices in this family have a Class I recall. 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. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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? (4)

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
*K020353Omnia X/XS Ultrasound System
Summary page 1
…2.1560 Product Code 90-IYO Diagnostic Ultrasound Transducer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: K020353, 2/13/2002, SONOLINE G50 and SONOLINE G60 S. K0321 11, 7/18/2003, ACUSON CV70 Cardiovascular System K003525,…
Siemens Medical Systems, Inc.2002—
*K032111Acuson CV70 Cardiovascular System
Summary page 1
…d Transducer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: K020353, 2/13/2002, SONOLINE G50 and SONOLINE G60 S. K0321 11, 7/18/2003, ACUSON CV70 Cardiovascular System K003525, 11/22/2000, Medison Voluson 730 K0031 25, 10/20/2000,…
Siemens Medical Solutions USA, Inc.20031
*K003525Voluson 730 Diagnostic Ultrasound System
Summary page 1
…TX 3. Predicate Device: K020353, 2/13/2002, SONOLINE G50 and SONOLINE G60 S. K0321 11, 7/18/2003, ACUSON CV70 Cardiovascular System K003525, 11/22/2000, Medison Voluson 730 K0031 25, 10/20/2000, SONOLINE Elegra (with AxiuSTm Automated OB Calipers and 3D…
Medison America, Inc.2000—
*K003125Sonoline Elegra Diagnostic Ultrasound System
Summary page 1
…2/13/2002, SONOLINE G50 and SONOLINE G60 S. K0321 11, 7/18/2003, ACUSON CV70 Cardiovascular System K003525, 11/22/2000, Medison Voluson 730 K0031 25, 10/20/2000, SONOLINE Elegra (with AxiuSTm Automated OB Calipers and 3D measurements) 4. Device Description:…
Siemens Medical Solutions USA, Inc.2000—

Also cleared against K020353: 8 other devices →

What descends from it? (950)

See all 950

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

NumberDeviceApplicantDecidedDescendants
K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004927
K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.2005926
K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005921
K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.2005806
K043078Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C2004196
K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
  • K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
  • 3 of the 18 ancestors have a recall of any class.
  • Of its descendants, K043016 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 927 descendants of its own.
  • 8 other devices also cite its predicate K020353.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

What is it indicated for?

Diagnostic imaging or fluid flow analysis of the human body as follows:

Indications for use as stated in the FDA summary.

Also cleared against K020353

8 other devices cite the same predicate.

  • K071314Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2007
  • K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
  • K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 20054 recalls
  • K043452Titan High Resolution Ultrasound System and Sonosite Ultrasound SystemSonosite,Inc. · 2004
  • K042833Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
  • K040502Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004

More from Siemens Medical Solutions USA, Inc.

798 FDA decisions under this applicant name. See the company

  • K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc. · 2026
  • K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc. · 2026
  • K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2026
  • P140011/S009MAMMOMAT B.brilliant with Tomosynthesis OptionSiemens Medical Solutions USA, Inc. · 2026
  • K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · 2026

Recent decisions in IYN

The IYN category page

  • K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K040060 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040060: Sonoline G50 and G60 S Diagnostic Ultrasound Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040060

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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