510(k) · Cleared
ClearedProsound F75 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Aloka Medical, Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 16, 2014 as substantially equivalent to K123828 (Hitachi Aloka Medical, Ltd., 2013) after a 35-day review. Its family tree reaches back 6 generations to 1996. 60 later devices descend from it.
- Decided
- Apr 16, 2014
- Review
- 35 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954022 (1996). 11 ancestors in all. 60 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK954022 Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd. · 1996
- 5 generations backK992663 Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
- 4 generations backK032875 Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA · 2003
- 3 generations backK043196 Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd. · 2004
- 2 generations backK110207 Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2011
- 1 generation backK123828 Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2013 · Recalled
- This deviceK140639 Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2014
- Descendant · cites it directly · 59 of its ownK153539 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- Descendant · 2 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 3 generations on · 39 of its ownK173204 RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- Descendant · 3 generations on · 37 of its ownK170493 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 4 generations on · 35 of its ownK172129 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · cites it directly59descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 2 generations on58descendants
- K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 3 generations on39descendants
- K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on37descendants
- K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 4 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954022 | Aloka Omniview Diagnostic Ultrasound System | Aloka Co., Ltd. | 1996 | — |
| −5 | K992663 | Aloka SSD-5500 Diagnostic Ultrasound System | Aloka Co., Ltd. | 1999 | — |
| −4 | K032875 | Aloka Model SSD-5500 V6.0 Ultrasound System | Aloka Co. Ltd USA | 2003 | — |
| −3 | K043196 | Aloka SSD-Alpha 10 Ultrasound System | Aloka Co., Ltd. | 2004 | — |
| −2 | K110207 | Aloka Prousound F75 Diagnostic Ultrasound System | Aloka Co., Ltd. | 2011 | — |
| −1 | K123828 | Prosound F75 Diagnostic Ultrasound System | Hitachi Aloka Medical, Ltd. | 2013 | 1 |
| 0 (this device) | K140639 | Prosound F75 Diagnostic Ultrasound System | Hitachi Aloka Medical, Ltd. | 2014 | — |
| +1 | K153539 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| +2 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +3 | K173204 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| +3 | K170493 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +4 | K172129 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 10 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K123828 | Prosound F75 Diagnostic Ultrasound SystemSummary page 5…ar P P P P P Note 1, 2 Vessel Other (spec.) N = new indication. P = previously cleared by FDA (K123828) Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD *: Specification… | 2013 |
| † | K122537 | Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0 | 2013 |
| † | K110673 | HI Vision Ascendus Diagnostic Ultrasound Scanner | 2011 |
| † | K130058 | Endoscopic Ultrasound Center EU-Y0008 | 2013 |
What descends from it? (60)
See all 601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153539 | RS80A Diagnostic Ultrasound System | 2016 | 59 |
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 18 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K153539 (Samsung Medison Co., Ltd., 2016) has gone furthest, with 59 descendants of its own.
- 1 other device also cites its predicate K123828.
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. 2014, 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 Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications.
The device is not indicated for Ophthalmic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140639: Prosound F75 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140639
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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