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 Apr 19, 2016 as substantially equivalent to K133134 (FUJIFILM Sonosite, Inc., 2013) and 1 other predicate after a 40-day review. Its family tree reaches back 1 generation to 2006. 6 later devices descend from it.
- Decided
- Apr 19, 2016
- Review
- 40 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K062571 (2006). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK062571 Longport Episcan, Model-I-200Longport, Inc. · 2006
- This deviceK160674 Fujifilm Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK190476 FUJIFILM Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK233112 HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK254099 EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound…Samsung Medison Co., Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK263182 EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound…Samsung Medison Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK221568 KOLO Evolution XHD Series Ultrasound Diagnostic SystemKolo Medical (Suzhou) Co., Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190476FUJIFILM Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2019 · cites it directly4descendants
- K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2023 · 2 generations on2descendants
- K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd. · 2026 · 3 generations on1descendant
- K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd. · 2026 · 4 generations on0descendants
- K221568KOLO Evolution XHD Series Ultrasound Diagnostic SystemKolo Medical (Suzhou) Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062571 | Longport Episcan, Model-I-200 | Longport, Inc. | 2006 | — |
| 0 (this device) | K160674 | Fujifilm Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2016 | — |
| +1 | K190476 | FUJIFILM Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2019 | — |
| +2 | K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023 | — |
| +3 | K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System… | Samsung Medison Co., Ltd. | 2026 | — |
| +4 | K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System… | Samsung Medison Co., Ltd. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K133134 | X-Porte Ultrasound SystemSummary page 8…892.1560 IYO 3) Identification of the predicate or legally marketed device: SonoSite X-Porte ultrasound system (K133134) (Primary Predicate) EpiScan I-200 (k062571) (Secondary predicate)… | 2013 |
| * | K062571 | Longport Episcan, Model-I-200Summary page 8…IYO 3) Identification of the predicate or legally marketed device: SonoSite X-Porte ultrasound system (K133134) (Primary Predicate) EpiScan I-200 (k062571) (Secondary predicate) Page 3 of 7… | 2006 |
What descends from it? (6)
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?
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. 2016, 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
Pediatric
Small Organ (breast, thyroid, testicles, prostrate)
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Peripheral vessel
Dermatological
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/K160674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160674: 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/K160674
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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