510(k) · Cleared
ClearedL7 Transducer Used on Aspen Model Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuson Corp. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Nov 5, 1997 as substantially equivalent to K934915 (Acuson Corp., 1994) after a 79-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Nov 5, 1997
- Review
- 79 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934915 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK934915 Acuson Model 2001Acuson Corp. · 1994
- This deviceK973079 L7 Transducer Used on Aspen Model Ultrasound SystemAcuson Corp. · 1997
- Descendant · cites it directly · 0 of its ownK990400 Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging…Hewlett-Packard Co. · 1999
Most influential descendants
Showing 1 of 1 · See all- K990400Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging SystemHewlett-Packard Co. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934915 | Acuson Model 2001 | Acuson Corp. | 1994 | — |
| 0 (this device) | K973079 | L7 Transducer Used on Aspen Model Ultrasound System | Acuson Corp. | 1997 | — |
| +1 | K990400 | Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System | Hewlett-Packard Co. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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 |
|---|---|---|---|
| * | K934915 | Acuson Model 2001 Our OCR of the scanned summary read “K934915/S1” beside “510(k)”; FDA’s K934915 is the only number that fits it and was decided on the date printed beside it. Summary page 1…L. DEVICE DESCRIPTION The Aspen model ultrasound system and L7 transducer is a general purpose diagnostic ultrasound system that received marketing clearance via 510(k) K934915/S1 on October 21, 1994. For the musculoskeletal indication for use described above, the device consists of the L7, a 128 element,… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990400 | Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System | 1999 | 0 |
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?
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 | — |
What is it indicated for?
The L7 when used with Aspen ultrasound system is capable of providing diagnostically useful images of anatomy and pathology in the major bone, joint, and muscle groups of the human body. Specific anatomy and pathology in the neck, shoulders, arms, elbows, wrist, hand, hips and pelvis, legs, knees, ankles and feet can be imaged. The images obtained depict anatomical structures and regions of increased and reduced blood flow which are useful to physicians in detecting normal and abnormal conditions in these regions of the body.
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/K973079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973079: L7 Transducer Used on Aspen Model 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/K973079
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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