510(k) · Cleared
ClearedSenosonix Ultrasound Breast Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Senorx, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Sep 25, 2007 as substantially equivalent to K023923 (Senorx, Inc., 2002) and 2 other predicates after a 15-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Sep 25, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935595 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 3 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 2 generations backK020630 Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation · 2002
- 1 generation backK061827 Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2006
- This deviceK072541 Senosonix Ultrasound Breast Biopsy SystemSenorx, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −3 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −2 | K020630 | Ultrasonix Ergosonix 500 Ultrasound Scanner | Ultrasonix Medical Corporation | 2002 | — |
| −1 | K061827 | Sonix Ultrasound Scanner | Ultrasonix Medical Corporation | 2006 | — |
| 0 (this device) | K072541 | Senosonix Ultrasound Breast Biopsy System | Senorx, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K023923 | Senocor 360 Circumferential Vacuum Assisted Biopsy Device, 8 GaugeSummary page 1…TYO Diagnostic Ultrasound Transducer 892.1570 ITX Review category Tier II Regulatory class 1I Predicate device K023923 SenoCor 360 Circumferential Vacuum-Assisted Biopsy Device K04… | 2002 |
| * | K040842 | Senorx Biopsy Device IISummary page 1…s 1I Predicate device K023923 SenoCor 360 Circumferential Vacuum-Assisted Biopsy Device K040842 SenoRx Biopsy Device IT K061827 Sonix Ultrasound Scanner Decision date 12/11//2002… | 2004 |
| * | K061827 | Sonix Ultrasound ScannerSummary page 1…Circumferential Vacuum-Assisted Biopsy Device K040842 SenoRx Biopsy Device IT K061827 Sonix Ultrasound Scanner Decision date 12/11//2002 (K023923) 4/30/2004 (K04… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
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 SenoSonix Ultrasound Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict…
Read the full statement (166 words)
The SenoSonix Ultrasound Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The ultrasound module is intended for use in obstetrics/gynecology and general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies.
The specific intended uses of the ultrasound system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), small organ (breast, thyroid, testicle), pediatric and fetal imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072541: Senosonix Ultrasound Breast Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072541
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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