510(k) · Cleared
ClearedSonoVision Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissue Differentiation Intelligence, LLC · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 12, 2020 as substantially equivalent to K132736 (Rivanna Medical, LLC, 2014) after a 191-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Mar 12, 2020
- Review
- 191 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K935595 (1995). 93 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations between
- 3 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 2 generations backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- 1 generation backK132736 Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014
- This deviceK192388 SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC · 2020
Show all 11 generations
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 9 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 8 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 7 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 5 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 2 generations backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- 1 generation backK132736 Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014
- This deviceK192388 SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −10 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −9 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −8 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −7 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −5 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| −2 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| −1 | K132736 | Accuro 3000 Ultrasound Scanner | Rivanna Medical, LLC | 2014 | — |
| 0 (this device) | K192388 | SonoVision Ultrasound Imaging System | Tissue Differentiation Intelligence, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 5 | 0 |
| 1999 | 11 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
| 2009 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K132736 | Accuro 3000 Ultrasound ScannerSummary page 4…Reference Predicate Accuro™ 3000 Ultrasound System Esaote 6200 and 6250 Ultrasound System 510(k) Number K132736 K153277 Classification Code IYO, ITX IYN, IYO, ITX… | 2014 |
| † | K153277 | 6200 Ultrasound System and 6250 Ultrasound System | 2016 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 93 ancestors have a recall of any class.
- 1 other device also cites its predicate K132736.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The SonoVision™ Ultrasound Imaging System is a general purpose ultrasound system intended for use by a qualified physician for the visualization and evaluation of nerves, vascular and other anatomical structures. The system provides imaging assistance in spinal procedure applications.
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/K192388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192388: SonoVision 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/K192388
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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