510(k) · Cleared
ClearedAloka SSD-Alpha 7 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aloka Co., Ltd. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Aug 30, 2007 as substantially equivalent to K043196 (Aloka Co., Ltd., 2004) after a 14-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.
- Decided
- Aug 30, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954022 (1996). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK954022 Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd. · 1996
- 3 generations backK992663 Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
- 2 generations backK032875 Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA · 2003
- 1 generation backK043196 Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd. · 2004
- This deviceK072285 Aloka SSD-Alpha 7 Ultrasound SystemAloka Co., Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK122537 Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model…Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · 2013
- Descendant · 2 generations on · 1 of its ownK140854 Intra-Operative Ultrasound TransducerHitachi Aloka Medical, Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK142618 Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic…Hitachi Aloka Medical America, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K122537Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · 2013 · cites it directly2descendants
- K140854Intra-Operative Ultrasound TransducerHitachi Aloka Medical, Ltd. · 2014 · 2 generations on1descendant
- K142618Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System…Hitachi Aloka Medical America, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954022 | Aloka Omniview Diagnostic Ultrasound System | Aloka Co., Ltd. | 1996 | — |
| −3 | K992663 | Aloka SSD-5500 Diagnostic Ultrasound System | Aloka Co., Ltd. | 1999 | — |
| −2 | K032875 | Aloka Model SSD-5500 V6.0 Ultrasound System | Aloka Co. Ltd USA | 2003 | — |
| −1 | K043196 | Aloka SSD-Alpha 10 Ultrasound System | Aloka Co., Ltd. | 2004 | — |
| 0 (this device) | K072285 | Aloka SSD-Alpha 7 Ultrasound System | Aloka Co., Ltd. | 2007 | — |
| +1 | K122537 | Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha… | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2013 | — |
| +2 | K140854 | Intra-Operative Ultrasound Transducer | Hitachi Aloka Medical, Ltd. | 2014 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K043196 | Aloka SSD-Alpha 10 Ultrasound SystemSummary page 1…0, 90 ITX Ultrasonic Pulsed Echo Imaging System., 21 CFR 892.1560, 90 IYO 3. Marketed Device: Aloka SSD-Alpha 10 Diagnostic Ultrasound System K043196, (90-IYN,ITX,IYO) ( A device currently in commercial distribution) 4. Device Description: The Aloka SSD-A… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122537 | Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0 | 2013 | 2 |
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 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K122537 (Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical, 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K043196.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal /Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Urology (including prostate), Transesophageal, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular).
The Aloka SSD-Alpha 7 is not indicated for ophthalmic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072285: Aloka SSD-Alpha 7 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/K072285
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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