510(k) · Cleared
ClearedModel FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fukuda Denshi USA, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 30, 2008 as substantially equivalent to K033209 (Fukuda Denshi USA, Inc., 2003) and 1 other predicate after an 18-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Sep 30, 2008
- Review
- 18 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922208 (1993). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK922208 Fukuda Denshi Model UF-4500Fukuda Denshi USA, Inc. · 1993
- 3 generations backK955543 Ultrasound System Model UF-3500Fukuda Denshi USA, Inc. · 1997
- 2 generations backK990401 Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning…Fukuda Denshi USA, Inc. · 1999
- 1 generation backK033209 Fukuda Denshi Model FF Sonic UF-750XTFukuda Denshi USA, Inc. · 2003
- This deviceK082656 Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitFukuda Denshi USA, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922208 | Fukuda Denshi Model UF-4500 | Fukuda Denshi USA, Inc. | 1993 | — |
| −3 | K955543 | Ultrasound System Model UF-3500 | Fukuda Denshi USA, Inc. | 1997 | — |
| −2 | K990401 | Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning System with… | Fukuda Denshi USA, Inc. | 1999 | — |
| −1 | K033209 | Fukuda Denshi Model FF Sonic UF-750XT | Fukuda Denshi USA, Inc. | 2003 | — |
| 0 (this device) | K082656 | Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging Unit | Fukuda Denshi USA, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K033209 | Fukuda Denshi Model FF Sonic UF-750XTSummary page 2…functionality to the original Fukuda Denshi Diagnostic Ultrasound System that is already cleared under premarket notification number K#033209, and another predicate device noted below: Predicate Device I Ma… | 2003 |
| * | K053258 | Eub-6500 Diagnostic Ultrasound ScannerSummary page 2…Predicate Device I Manufactr:: er I Model 510(k) Numbe Fiirst Hitachi medical EUB-6500 K#053258 Device Description: The Fukuda Denshi Model FF Sonic UF-750XT Ultrasound System is a general purpose, mobile… | 2005 |
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 15 years and passes through 1 company; a new generation was cleared every 4.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K033209.
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. 2008, 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 device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes, etc.), cardiac (adult and pediatric), transvaginal, peripheral vessel, and musculo-skeletal (Conventional and Superficial). The device incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The device is a prescription device intended to be use by or on…
Read the full statement (117 words)
The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes, etc.), cardiac (adult and pediatric), transvaginal, peripheral vessel, and musculo-skeletal (Conventional and Superficial). The device incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The device is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082656: Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082656
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