510(k) · Cleared
Recalled · Class III · 2025Hdi 5000 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Ultrasound, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 8, 2004 as substantially equivalent to K961459 (Advanced Technology Laboratories, Inc., 1997) and 5 other predicates after a 15-day review. Its family tree reaches back 2 generations to 2000. 677 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 8, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 4
- Predicates
- 6
Its longest line of descent runs back 2 generations to K001400 (2000). 7 ancestors in all, the oldest K940942 (1997). 677 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK001400 Elegra Millennium Enhanced Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2000 · Recalled
- 1 generation backK023720 Sonoline Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2002 · Recalled
- This deviceK034003 Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2004
- Descendant · cites it directly · 676 of its ownK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- Descendant · 2 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
- Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- Descendant · 4 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
Showing 5 of 677 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 677 · See all- K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · cites it directly676descendants
- K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 2 generations on584descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
- K110943Logiq E9GE Healthcare · 2011 · 4 generations on472descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001400 | Elegra Millennium Enhanced Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2000 | 1 |
| −1 | K023720 | Sonoline Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2002 | 1 |
| 0 (this device) | K034003 | Hdi 5000 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2004 | — |
| +1 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| +2 | K080935 | Sonix MDP Ultrasound Scanner | Ultrasonix Medical Corporation | 2008 | — |
| +2 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +3 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| +4 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 14 | 0 |
| 2012 | 25 | 0 |
| 2013 | 25 | 0 |
| 2014 | 39 | 0 |
| 2015 | 38 | 0 |
| 2016 | 48 | 0 |
| 2017 | 53 | 0 |
| 2018 | 52 | 0 |
| 2019 | 40 | 0 |
| 2020 | 57 | 0 |
| 2021 | 42 | 0 |
| 2022 | 47 | 0 |
| 2023 | 42 | 0 |
| 2024 | 48 | 0 |
| 2025 | 54 | 0 |
| 2026 | 35 | 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? (6)
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 |
|---|---|---|---|
| * | K961459 | Level 10 HdiSummary page 1…t the HDI 5000 system and transducers are substantially equivalent to the following currently marketed ultrasound system and transducers: HDI 5000, K96 1459, K991671, K002003; GE Voluson 730, K003525; Voluson 530, K940942; Antares, K023720- 4) Device Description… | 1997 |
| * | K991671 | Hdi 5000 Diagnostic Ultrasound SystemSummary page 1…5000 system and transducers are substantially equivalent to the following currently marketed ultrasound system and transducers: HDI 5000, K96 1459, K991671, K002003; GE Voluson 730, K003525; Voluson 530, K940942; Antares, K023720- 4) Device Description & Technic… | 1999 |
| * | K002003 | Hdi 5000 Ultrasound System with Extended Field of View ImagingSummary page 1…em and transducers are substantially equivalent to the following currently marketed ultrasound system and transducers: HDI 5000, K96 1459, K991671, K002003; GE Voluson 730, K003525; Voluson 530, K940942; Antares, K023720- 4) Device Description & Technical Compar… | 2000 |
| * | K003525 | Voluson 730 Diagnostic Ultrasound SystemSummary page 1…bstantially equivalent to the following currently marketed ultrasound system and transducers: HDI 5000, K96 1459, K991671, K002003; GE Voluson 730, K003525; Voluson 530, K940942; Antares, K023720- 4) Device Description & Technical Comparison to Predicate Devices… | 2000 |
| * | K940942 | Combison 530 Diagnostic Ultrasound ScannerSummary page 1…to the following currently marketed ultrasound system and transducers: HDI 5000, K96 1459, K991671, K002003; GE Voluson 730, K003525; Voluson 530, K940942; Antares, K023720- 4) Device Description & Technical Comparison to Predicate Devices The HDI 5000 system… | 1997 |
| * | K023720 | Sonoline Antares Ultrasound SystemSummary page 1…currently marketed ultrasound system and transducers: HDI 5000, K96 1459, K991671, K002003; GE Voluson 730, K003525; Voluson 530, K940942; Antares, K023720- 4) Device Description & Technical Comparison to Predicate Devices The HDI 5000 system and transducer(s)… | 2002 |
What descends from it? (677)
See all 6774 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2025 | Class III | Z-1618-2026 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2346-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2358-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2357-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K053069 (Sonosite,Inc., 2005) has gone furthest, with 676 descendants of its own.
- 15 other devices also cite its predicate K961459.
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.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K034003: Hdi 5000 Diagnostic 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/K034003
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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