510(k) · Cleared
ClearedEub-6500 Diagnostic Ultrasound Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 9, 2005 as substantially equivalent to K013723 (Hitachi Medical Corp., 2002) after a 17-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it.
- Decided
- Dec 9, 2005
- Review
- 17 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013723 (2002). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013723 Modification to: Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2002 · Recalled
- This deviceK053258 Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2005
- Descendant · cites it directly · 2 of its ownK110241 Endologix GuidewireTechdevice Corporation · 2011
- Descendant · 2 generations on · 1 of its ownK152177 SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015
- Descendant · 3 generations on · 0 of its ownK243061 SonoStik Guide Wire IntroducerSonostik, LLC · 2024
- Descendant · cites it directly · 0 of its ownK082656 Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitFukuda Denshi USA, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K110241Endologix GuidewireTechdevice Corporation · 2011 · cites it directly2descendants
- K152177SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015 · 2 generations on1descendant
- K243061SonoStik Guide Wire IntroducerSonostik, LLC · 2024 · 3 generations on0descendants
- K082656Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitFukuda Denshi USA, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013723 | Modification to: Eub-6500 Diagnostic Ultrasound Scanner | Hitachi Medical Corp. | 2002 | 2 |
| 0 (this device) | K053258 | Eub-6500 Diagnostic Ultrasound Scanner | Hitachi Medical Corp. | 2005 | — |
| +1 | K110241 | Endologix Guidewire | Techdevice Corporation | 2011 | — |
| +2 | K152177 | SonoStik IV Guide Wire Introducer | Sonostik, LLC | 2015 | — |
| +3 | K243061 | SonoStik Guide Wire Introducer | Sonostik, LLC | 2024 | — |
| +1 | K082656 | Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging Unit | Fukuda Denshi USA, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K013723 | Modification to: Eub-6500 Diagnostic Ultrasound ScannerSummary page 5…p g p Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.) P = Previously Cleared, K013723 *Combination of each operating mode, B, M, PWD, CWD and Color… | 2002 |
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?
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.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K053258 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053258: Eub-6500 Diagnostic Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053258
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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