510(k) · Cleared
Recalled · 2008Modification to: Eub-6500 Diagnostic Ultrasound Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Corp. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Feb 6, 2002 after an 89-day review. The FDA summary names no predicate by number. 15 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 6, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 2
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK013723 Modification to: Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2002
- Descendant · cites it directly · 9 of its ownK023401 EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003
- Descendant · 2 generations on · 6 of its ownK090197 EG-3870UTKPentax Medical Company · 2009 · Recalled
- Descendant · 3 generations on · 5 of its ownK130247 Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 4 of its ownK162447 PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I.…Pentax of America, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK053258 Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2005
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K023401EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003 · cites it directly9descendants
- K090197EG-3870UTKPentax Medical Company · 2009 · 2 generations on6descendants
- K130247Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013 · 3 generations on5descendants
- K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex…Pentax of America, Inc. · 2017 · 4 generations on4descendants
- K053258Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2005 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013723 | Modification to: Eub-6500 Diagnostic Ultrasound Scanner | Hitachi Medical Corp. | 2002 | — |
| +1 | K023401 | EG-3830UT, Video Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2003 | — |
| +2 | K090197 | EG-3870UTK | Pentax Medical Company | 2009 | 2 |
| +3 | K130247 | Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision Preirus | Pentax of America, Inc. | 2013 | 1 |
| +4 | K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope… | Pentax of America, Inc. | 2017 | — |
| +1 | K053258 | Eub-6500 Diagnostic Ultrasound Scanner | Hitachi Medical Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (15)
See all 152 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2008 | Not classified | Z-2054-2009 | Software design | The firm's parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to become intermingled and consequently… |
| May 7, 2004 | Not classified | Z-1005-04 | Other | Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023401 (Pentax Precision Instrument Corp., 2003) has gone furthest, with 9 descendants of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis if 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/K013723 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013723: Modification to: Eub-6500 Diagnostic Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013723
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026