510(k) · Cleared
ClearedUltrasound Scanner, Hudson Models 8000 and 9000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hudson Diagnostic Imaging, LLC · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 10, 2004 as substantially equivalent to K031552 (Medison America, Inc., 2003) and 1 other predicate after a 63-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jun 10, 2004
- Review
- 63 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K924432 (1993). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 5 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 4 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 3 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 2 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 1 generation backK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
- This deviceK040926 Ultrasound Scanner, Hudson Models 8000 and 9000Hudson Diagnostic Imaging, LLC · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −5 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −4 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −3 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −2 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −1 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
| 0 (this device) | K040926 | Ultrasound Scanner, Hudson Models 8000 and 9000 | Hudson Diagnostic Imaging, LLC | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031552 | Mycolor 202 Diagnostic Ultrasound System and TransducersSummary page 1…Medison America Inc. 11075 Knott Avenue Cypress, CA 90630 Scanner 5 10(k) Number: K031552 Scanner TradecNames: Aloka SSD-900 Ultrasound Imaging System** Manufactured and Distributed By::… | 2003 |
| * | K983879 | Aloka SSD-900 Diagnostic Ultrasound SystemSummary page 1…o. Ltd. 10 Fairfield Boulevard Wallingford, CT 06492 Scanner 5 1 0(k) Numbers: K983879 Scanner Trade Names:Hudson 2020, 2040, and 2060 Ultrasound Imaging Systems Distributed by :… | 1999 |
| Kept off the family tree | K011284 | FDA’s K011284 is Thin Film Dressing for Ultrasound Exam Our OCR of the scanned summary read K011284, FDA’s number for Thin Film Dressing for Ultrasound Exam (Martin E. Wendelken). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hudson 2020, 2040, and 2060 Ultrasound Imaging Systems”. Kept off the family tree. | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K031552.
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/K040926 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040926: Ultrasound Scanner, Hudson Models 8000 and 9000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040926
Report an extraction error
Are you the manufacturer?
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