510(k) Report

510(k) · Cleared

Cleared

Sonoline G20 Diagnostic Ultrasound Systems

K071314510(k) TraditionalCleared May 22, 200712-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. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on May 22, 2007 as substantially equivalent to K042833 (Siemens Medical Solutions USA, Inc., 2004) and 3 other predicates after a 12-day review. Its family tree reaches back 5 generations to 1994.

Decided
May 22, 2007
Review
12 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K933202 (1994). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor1995: 3 other ancestorsK933202 · Venus Diagnostic Ultrasound System · GE Medical Systems · 1994K970901 · GE Logiq 500 Diagnostic Ultrasound System · GE Medical Systems · 1997K991611 · GE Logiq 500 · General Electric Co. · 1999K040502 · Sonoline Ebisu Diagnostic Ultrasound Systems · Siemens Medical Solutions USA, Inc. · 2004K042833 · Sonoline G20 Diagnostic Ultrasound Systems · Siemens Medical Solutions USA, Inc. · 20041990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K042833 · Sonoline G20 Diagnostic Ultrasound Systems · Siemens Medical Solutions USA, Inc. · 2004K040502 · Sonoline Ebisu Diagnostic Ultrasound Systems · Siemens Medical Solutions USA, Inc. · 2004K991611 · GE Logiq 500 · General Electric Co. · 1999K970901 · GE Logiq 500 Diagnostic Ultrasound System · GE Medical Systems · 1997K933202 · Venus Diagnostic Ultrasound System · GE Medical Systems · 1994−50
  1. Root · 5 generations backK933202 Venus Diagnostic Ultrasound SystemGE Medical Systems · 1994
  2. 4 generations backK970901 GE Logiq 500 Diagnostic Ultrasound SystemGE Medical Systems · 1997
  3. 3 generations backK991611 GE Logiq 500General Electric Co. · 1999
  4. 2 generations backK040502 Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
  5. 1 generation backK042833 Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
  6. This deviceK071314 Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K933202Venus Diagnostic Ultrasound SystemGE Medical Systems1994—
−4K970901GE Logiq 500 Diagnostic Ultrasound SystemGE Medical Systems1997—
−3K991611GE Logiq 500General Electric Co.1999—
−2K040502Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004—
−1K042833Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004—
0 (this device)K071314Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199530
200210
FIG. 1 — Lineage of K071314, 1994–2007Source: 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.

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? (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
*K042833Sonoline G20 Diagnostic Ultrasound Systems
Summary page 1
…892.1560 Product Code 90-IYO Diagnostic Ultrasound Transducer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: K042833, 10/27/2004, SONOLINE G20 Diagnostic Ultrasound System K040502, 03/09/2004, SONOLINE G20 Diagnostic Ultrasound System…
Siemens Medical Solutions USA, Inc.2004—
*K040502Sonoline Ebisu Diagnostic Ultrasound Systems
Summary page 1
…ducer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: K042833, 10/27/2004, SONOLINE G20 Diagnostic Ultrasound System K040502, 03/09/2004, SONOLINE G20 Diagnostic Ultrasound System K020353, 02/13/2002, SONOLINE G50 & G60 S Diagnostic Ultrasound S…
Siemens Medical Solutions USA, Inc.2004—
*K020353Omnia X/XS Ultrasound System
Summary page 1
…redicate Device: K042833, 10/27/2004, SONOLINE G20 Diagnostic Ultrasound System K040502, 03/09/2004, SONOLINE G20 Diagnostic Ultrasound System K020353, 02/13/2002, SONOLINE G50 & G60 S Diagnostic Ultrasound Systems K946179, 10/03/1995, marketed as SONOLINE Adara Diagnost…
Siemens Medical Systems, Inc.2002—
*K946179Siemens Sonoline 4XX
Summary page 1
…System K040502, 03/09/2004, SONOLINE G20 Diagnostic Ultrasound System K020353, 02/13/2002, SONOLINE G50 & G60 S Diagnostic Ultrasound Systems K946179, 10/03/1995, marketed as SONOLINE Adara Diagnostic Ultrasound System 4. Device Description: The G20 is a general…
Siemens Medical Solutions USA, Inc.1995—

Also cleared against K042833: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
  • None of the 9 ancestors has a recall.
  • 1 other device also cites its predicate K042833.

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. 2007, 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 G20TM ultrasound imaging systems are intended for the following

applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts,

Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, 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.

Also cleared against K042833

1 other device cites the same predicate.

  • K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 20051 recall

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https://510kreport.com/device/K071314 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071314: Sonoline G20 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/K071314

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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