510(k) · Cleared
ClearedDeepsight NeedleVue LC1 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DeepSight Technology, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 1, 2025 as substantially equivalent to K152309 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2015) after a 171-day review. Its family tree reaches back 18 generations to 1995.
- Decided
- Aug 1, 2025
- Review
- 171 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K935595 (1995). 150 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 2 generations backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- 1 generation backK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · Recalled
- This deviceK250381 Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc. · 2025
Show all 18 generations
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 16 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 15 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 14 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 9 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 8 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 7 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 6 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 5 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 4 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 3 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 2 generations backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- 1 generation backK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · Recalled
- This deviceK250381 Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −17 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −16 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −15 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −14 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −12 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −9 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −8 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −7 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −6 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −5 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −4 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −3 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| −2 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| −1 | K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015 | 1 |
| 0 (this device) | K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0Summary page 5…Device Trade/Proprietary Name: DeepSight NeedleVue LC1 Ultrasound System Classification name, Class II Predicate Device: GE Healthcare Logiq E9 Ultrasound System (K152309) Subject Device Description: The DeepSight NeedleVue LC1 Ultrasound System is a general- purpose diagnostic ultrasound system t… | 2015 |
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 30 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 49 of the 150 ancestors have a recall of any class.
- 3 other devices also cite its predicate K152309.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The DeepSight NeedleVue LC1 Ultrasound System is intended for use in Abdominal, Pediatric, Small Organ, Peripheral Vascular, Fetal, Urological, and Musculoskeletal Conventional and Superficial Imaging. This device is indicated for Prescription Use Only and by qualified healthcare professionals (HCPs). The DeepSight NeedleVue LC1 ultrasound system is intended to be used by qualified and trained physicians or sonographers with at least basic ultrasound knowledge. The operator must have read and understood the user manual. The DeepSight NeedleVue LC1 ultrasound system is intended to be used in medical practices and clinical environments including healthcare facilities, hospitals and clinics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250381: Deepsight NeedleVue LC1 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/K250381
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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