510(k) · Cleared
ClearedBSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter 2.9F/20MHZ/37411/
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Imaging Systems, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jun 20, 1997 after a 165-day review. The FDA summary names its predicate without a number. 3 of the 1,109 devices in its family, counting itself, have a Class I recall. 1,108 later devices descend from it.
- Decided
- Jun 20, 1997
- Review
- 165 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 0
1,108 later devices descend from it, 5 citing it directly. 3 of the 1,109 devices in this family, counting this one, have a Class I recall.
- This deviceK970049 BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC…Cardiovascular Imaging Systems, Inc. · 1997
- Descendant · cites it directly · 1,093 of its ownK992631 Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · Recalled
- Descendant · 2 generations on · 1,069 of its ownK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- Descendant · 3 generations on · 1,003 of its ownK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- Descendant · 4 generations on · 988 of its ownK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 5 generations on · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Showing 5 of 1,108 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,108 · See all- K992631Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 1999 · cites it directly1,093descendants
- K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002 · 2 generations on1,069descendants
- K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003 · 3 generations on1,003descendants
- K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 4 generations on988descendants
- K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 5 generations on979descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath… | Cardiovascular Imaging Systems, Inc. | 1997 | — |
| +1 | K992631 | Acunav Diagnostic Ultrasound Catheter | Acuson Corp. | 1999 | 1 |
| +2 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| +3 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +4 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +5 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 12 | 0 |
| 2005 | 15 | 0 |
| 2006 | 13 | 0 |
| 2007 | 21 | 0 |
| 2008 | 20 | 0 |
| 2009 | 26 | 0 |
| 2010 | 24 | 0 |
| 2011 | 36 | 0 |
| 2012 | 42 | 0 |
| 2013 | 45 | 0 |
| 2014 | 55 | 0 |
| 2015 | 60 | 0 |
| 2016 | 67 | 0 |
| 2017 | 80 | 0 |
| 2018 | 70 | 0 |
| 2019 | 50 | 0 |
| 2020 | 78 | 0 |
| 2021 | 56 | 0 |
| 2022 | 62 | 0 |
| 2023 | 60 | 0 |
| 2024 | 68 | 0 |
| 2025 | 85 | 3 |
| 2026 | 56 | 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.
3 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? (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 |
|---|---|---|---|
| * | — | BSC, Sunnyvale - MicroView 2.9 F Coronary Imaging Catheter Named without a submission number | |
| * | — | BSC, Sunnyvale - MicroRail 3.2F Coronary Imaging Catheter Named without a submission number | |
| * | — | BSC, Natick (Medi-tech) - Sonicath 3.5 F Interventional Ultrasound Imaging Catheter Named without a submission number |
What descends from it? (1,108)
See all 1,1085 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992631 | Acunav Diagnostic Ultrasound Catheter | 1999 | 1,093 |
| K060947 | Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020 | 2006 | 11 |
| K092156 | Cad 12, Colonoscopy Assist Device | 2009 | 7 |
| K022860 | Atlantis PV Imaging Catheter, Model 36456 | 2002 | 0 |
| K982840 | BSC Sonicath Ultra Intravascular Ultrasound Imaging Wire with Detachable Adapter & BSC… | 1998 | 0 |
Has anything in its family been recalled? (3 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.
- K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 13 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 13 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K992631 (Acuson Corp., 1999) has gone furthest, with 1,093 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 | — |
What is it indicated for?
The Sonicath Ultra Imaging Catheter is intended for the ultrasound examination of peripheral and coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
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/K970049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970049: BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter 2.9F/20MHZ/37411/.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970049
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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