510(k) · Cleared
ClearedVoluson SWIFT; Voluson SWIFT+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 20, 2023 as substantially equivalent to K201828 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2020) after a 132-day review. Its family tree reaches back 23 generations to 1995. 1 later device descends from it.
- Decided
- Jun 20, 2023
- Review
- 132 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 23 generations to K935595 (1995). 127 ancestors in all, the oldest K863700 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations between
- 3 generations backK160162 Voluson P6, Voluson P8GE Healthcare · 2016
- 2 generations backK180535 Voluson P6 and Voluson P8GE Healthcare · 2018 · Recalled
- 1 generation backK201828 Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- This deviceK230346 Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC · 2023
- Descendant · cites it directly · 0 of its ownK250543 Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics · 2025
Show all 23 generations
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 22 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 21 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 20 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 19 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 18 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 17 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 16 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 15 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 14 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 13 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 12 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 11 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 10 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 9 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 8 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 7 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 6 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 5 generations backK142472 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare · 2015
- 4 generations backK152567 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare · 2015
- 3 generations backK160162 Voluson P6, Voluson P8GE Healthcare · 2016
- 2 generations backK180535 Voluson P6 and Voluson P8GE Healthcare · 2018 · Recalled
- 1 generation backK201828 Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- This deviceK230346 Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −22 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −21 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −20 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −19 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −18 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −17 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −16 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −15 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −14 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −13 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −12 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −11 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −10 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −9 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −8 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −7 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −6 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −5 | K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | GE Healthcare | 2015 | — |
| −4 | K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | GE Healthcare | 2015 | — |
| −3 | K160162 | Voluson P6, Voluson P8 | GE Healthcare | 2016 | — |
| −2 | K180535 | Voluson P6 and Voluson P8 | GE Healthcare | 2018 | 1 |
| −1 | K201828 | Voluson SWIFT, Voluson SWIFT+ | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| 0 (this device) | K230346 | Voluson SWIFT; Voluson SWIFT+ | Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC | 2023 | — |
| +1 | K250543 | Voluson™ Performance 16; Voluson™ Performance 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025 | — |
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 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 12 | 0 |
| 2005 | 11 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K201828 | Voluson SWIFT, Voluson SWIFT+Summary page 4…ic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Primary Predicate Device: K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System Reference Device(s): K210438 Versana P… | 2020 |
| † | K210438 | Versana Premier | 2021 |
| † | K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | 2022 |
| † | K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250543 | Voluson™ Performance 16; Voluson™ Performance 18 | 2025 | 0 |
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 28 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 33 of the 127 ancestors have a recall of any class.
- Of its descendants, K250543 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201828.
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. 2023, 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 Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson…
Read the full statement (167 words)
The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).
Mode of operation include: B, M, AMM (Anatomical M-Mode), PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, HD-Flow (High Definition-Flow), Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, B-Flow and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson SWIFT / Voluson™ SWIFT+ are intended to be used in a hospital or medical clinic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230346: Voluson SWIFT; Voluson SWIFT+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230346
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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