510(k) · Cleared
ClearedSA8800 Diagnostic Ultrasound System and Transducers,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison America, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 21, 1998 as substantially equivalent to K961459 (Advanced Technology Laboratories, Inc., 1997) after a 281-day review. Its family tree reaches back 1 generation to 1997. 215 later devices descend from it.
- Decided
- Aug 21, 1998
- Review
- 281 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961459 (1997). 215 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK961459 Level 10 HdiAdvanced Technology Laboratories, Inc. · 1997
- This deviceK974269 SA8800 Diagnostic Ultrasound System and Transducers,Medison America, Inc. · 1998
- Descendant · cites it directly · 209 of its ownK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- Descendant · cites it directly · 208 of its ownK992470 Ultramark 400C/Sonoace 6000 Ultrasound SystemAdvanced Technology Laboratories, Inc. · 1999
- Descendant · cites it directly · 207 of its ownK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- Descendant · cites it directly · 204 of its ownK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- Descendant · 2 generations on · 184 of its ownK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
Showing 5 of 215 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 215 · See all- K990970Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound…Medison America, Inc. · 1999 · cites it directly209descendants
- K992470Ultramark 400C/Sonoace 6000 Ultrasound SystemAdvanced Technology Laboratories, Inc. · 1999 · cites it directly208descendants
- K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · cites it directly207descendants
- K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001 · cites it directly204descendants
- K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · 2 generations on184descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961459 | Level 10 Hdi | Advanced Technology Laboratories, Inc. | 1997 | — |
| 0 (this device) | K974269 | SA8800 Diagnostic Ultrasound System and Transducers, | Medison America, Inc. | 1998 | — |
| +1 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| +1 | K992470 | Ultramark 400C/Sonoace 6000 Ultrasound System | Advanced Technology Laboratories, Inc. | 1999 | — |
| +1 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| +1 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| +2 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 5 | 0 |
| 2016 | 11 | 0 |
| 2017 | 15 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 14 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K961459 | Level 10 HdiSummary page 1…legally marketed device: Medison America, Inc believes that SA8800/HDI 1500 Ultrasound system is substantially equivalent to the currently marketed ATL HDI 5000 System, K961459. 510(¢k) Summary of Safety and Effectiveness Page 1 510(k) Premarket Notification SA 8800/HDI" 1500 Ultrasound S… | 1997 |
What descends from it? (215)
See all 2158 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound… | 1999 | 209 |
| K992470 | Ultramark 400C/Sonoace 6000 Ultrasound System | 1999 | 208 |
| K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | 2000 | 207 |
| K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | 2001 | 204 |
| K012867 | Sonoace 9900 Diagnostic Ultrasound System | 2001 | 132 |
| K070195 | Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B | 2007 | 0 |
| K993517 | Combison 530D/Voluson 530D, Tissue Harmonic Imaging (Thi) Option | 1999 | 0 |
| K984639 | The S-Vna 5-8(B) Diagnostic Ultrasound Transducer | 1999 | 0 |
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: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow…
Read the full statement (117 words)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K974269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974269: SA8800 Diagnostic Ultrasound System and Transducers,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974269
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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