510(k) · Cleared
ClearedProusound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 12, 2013 as substantially equivalent to K072285 (Aloka Co., Ltd., 2007) and 2 other predicates after a 235-day review. Its family tree reaches back 5 generations to 1996. 2 later devices descend from it.
- Decided
- Apr 12, 2013
- Review
- 235 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K954022 (1996). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK954022 Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd. · 1996
- 4 generations backK992663 Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
- 3 generations backK032875 Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA · 2003
- 2 generations backK043196 Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd. · 2004
- 1 generation backK072285 Aloka SSD-Alpha 7 Ultrasound SystemAloka Co., Ltd. · 2007
- This deviceK122537 Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model…Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · 2013
- Descendant · cites it directly · 1 of its ownK140854 Intra-Operative Ultrasound TransducerHitachi Aloka Medical, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK142618 Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic…Hitachi Aloka Medical America, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954022 | Aloka Omniview Diagnostic Ultrasound System | Aloka Co., Ltd. | 1996 | — |
| −4 | K992663 | Aloka SSD-5500 Diagnostic Ultrasound System | Aloka Co., Ltd. | 1999 | — |
| −3 | K032875 | Aloka Model SSD-5500 V6.0 Ultrasound System | Aloka Co. Ltd USA | 2003 | — |
| −2 | K043196 | Aloka SSD-Alpha 10 Ultrasound System | Aloka Co., Ltd. | 2004 | — |
| −1 | K072285 | Aloka SSD-Alpha 7 Ultrasound System | Aloka Co., Ltd. | 2007 | — |
| 0 (this device) | K122537 | Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha… | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2013 | — |
| +1 | K140854 | Intra-Operative Ultrasound Transducer | Hitachi Aloka Medical, Ltd. | 2014 | — |
| +2 | K142618 | Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound… | Hitachi Aloka Medical America, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K072285 | Aloka SSD-Alpha 7 Ultrasound SystemSummary page 1…Ultrasonic Pulsed Echo Imaging System., 21 CFR 892.1560, 90 IYO 3. Substantially Equivalent devices: Aloka 550- Alpha 7 Diagnostic Ultrasound System K072285 for probes and system. Aloka SSD-5500 (K(032875), Aloka Prosound F75 (KI 10207), and Atoka SSD-5000… | 2007 |
| * | K032875 | Aloka Model SSD-5500 V6.0 Ultrasound SystemSummary page 27…ediatric Cardiac, Neonatal Intra-cardiac Other (Specify) Peripheral Peripheral vascular Vessel Other (Specify) N = new indication for system; P= Previously cleared-K 032875 Combined: Note I: B/M, B/PWD, M/CD, B/CD/PWD Application: Intra-operative: (liver, pancreas, gall bladder,....) {PLEASE DO NOT W… | 2003 |
| * | K110207 | Aloka Prousound F75 Diagnostic Ultrasound SystemSummary page 51…Other (Specify) ________ N=onew indication for system, P- Previously cleared-K1 10207 Combined: Note 1: fl/I, BPWVD, M/CD, BICD/PWD ,Note 2: 8/CWD, B/CD/CWD (PLEASE DO NOT WRITE BELOW TH… | 2011 |
| Kept off the family tree | K011208 | FDA’s K011208 is Biover Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140854 | Intra-Operative Ultrasound Transducer | 2014 | 1 |
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 17 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K140854 (Hitachi Aloka Medical, Ltd., 2014) has gone furthest, with 1 descendant of its own.
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. 2013, 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 for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Intra-operative (Neuro), Laparoscopic, Pediatric, Neonatal Cephalic, Trans-rectal & vaginal, Musculoskeletal, Gynecological, Cardiac (Adult, Neonatal, Pediatric), TEE & Peripheral Vascular.
The device is not intended for ophthalmic applications.
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/K122537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122537: Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122537
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