510(k) · Cleared
ClearedFUJIFILM Sonosite Vevo MD Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FUJIFILM Sonosite, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 15, 2019 as substantially equivalent to K160674 (FUJIFILM Sonosite, Inc., 2016) after a 16-day review. Its family tree reaches back 2 generations to 2006. 4 later devices descend from it.
- Decided
- Mar 15, 2019
- Review
- 16 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K062571 (2006). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK062571 Longport Episcan, Model-I-200Longport, Inc. · 2006
- 1 generation backK160674 Fujifilm Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2016
- This deviceK190476 FUJIFILM Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK233112 HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK254099 EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound…Samsung Medison Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK263182 EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound…Samsung Medison Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK221568 KOLO Evolution XHD Series Ultrasound Diagnostic SystemKolo Medical (Suzhou) Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2023 · cites it directly2descendants
- K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd. · 2026 · 2 generations on1descendant
- K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd. · 2026 · 3 generations on0descendants
- K221568KOLO Evolution XHD Series Ultrasound Diagnostic SystemKolo Medical (Suzhou) Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062571 | Longport Episcan, Model-I-200 | Longport, Inc. | 2006 | — |
| −1 | K160674 | Fujifilm Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2016 | — |
| 0 (this device) | K190476 | FUJIFILM Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2019 | — |
| +1 | K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023 | — |
| +2 | K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System… | Samsung Medison Co., Ltd. | 2026 | — |
| +3 | K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System… | Samsung Medison Co., Ltd. | 2026 | — |
| +1 | K221568 | KOLO Evolution XHD Series Ultrasound Diagnostic System | Kolo Medical (Suzhou) Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K160674 | Fujifilm Sonosite Vevo MD Imaging SystemSummary page 8…892.1560 IYO 3) Identification of the predicate or legally marketed device: FUJIFILM SonoSite Vevo MD Imaging System (K160674) (Primary Predicate) SonoSite X-Porte ultrasound system (K171437) (Reference Predicate) 4) Device Description: The Vev… | 2016 |
| † | K171437 | SonoSite X-Porte Ultrasound System | 2017 |
What descends from it? (4)
2 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 13 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233112 (Samsung Medison Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K160674.
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. 2019, 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 Vevo MD Imaging System is a general purpose imaging system intended for use by a qualified physician for evaluation
by ultrasound imaging or fluid flow analysis of the human body.
Specific clinical applications and exam types include:
Abdominal
Dermatological
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Neonatal Cephalic
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast, thyroid, testicles, prostate)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190476: FUJIFILM Sonosite Vevo MD Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190476
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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