510(k) · Cleared
Cleared7050 Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosound, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jun 2, 1995 after a 273-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 185 devices in its family, counting itself, have a Class I recall. 184 later devices descend from it.
- Decided
- Jun 2, 1995
- Review
- 273 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 0
184 later devices descend from it, 2 citing it directly. 2 of the 185 devices in this family, counting this one, have a Class I recall.
- This deviceK944287 7050 Ultrasound Imaging SystemBiosound, Inc. · 1995
- Descendant · cites it directly · 113 of its ownK981293 7200 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- Descendant · 2 generations on · 112 of its ownK020112 50S Tringa Ultrasound Imaging SystemPie Medical · 2002
- Descendant · 3 generations on · 107 of its ownK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- Descendant · 4 generations on · 103 of its ownK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- Descendant · 5 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
Showing 5 of 184 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 184 · See all- K9812937200 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998 · cites it directly113descendants
- K02011250S Tringa Ultrasound Imaging SystemPie Medical · 2002 · 2 generations on112descendants
- K090505Speq Ultrasound SystemSignostics Pty, Ltd. · 2009 · 3 generations on107descendants
- K102153Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011 · 4 generations on103descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 5 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944287 | 7050 Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| +1 | K981293 | 7200 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| +2 | K020112 | 50S Tringa Ultrasound Imaging System | Pie Medical | 2002 | — |
| +3 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| +4 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| +5 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 9 | 0 |
| 2015 | 5 | 0 |
| 2016 | 10 | 0 |
| 2017 | 11 | 0 |
| 2018 | 9 | 0 |
| 2019 | 9 | 0 |
| 2020 | 12 | 0 |
| 2021 | 14 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 12 | 0 |
| 2025 | 20 | 2 |
| 2026 | 19 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (184)
See all 1842 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K981293 (Biosound Esaote, Inc., 1998) has gone furthest, with 113 descendants of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K944287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944287: 7050 Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944287
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026