510(k) · Cleared
Recalled · Class II · 2020Noblus Diagnostic Ultrasound Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Aloka Medical, Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 14, 2015 as substantially equivalent to K130308 (Hitachi Aloka Medical, Ltd., 2013) and 3 other predicates after a 142-day review. Its family tree reaches back 15 generations to 1995. 58 later devices descend from it. It has been recalled once.
- Decided
- Jan 14, 2015
- Review
- 142 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 15 generations to K935595 (1995). 93 ancestors in all, the oldest K891689 (1989). 58 later devices descend from it, 7 citing it directly.
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations between
- 3 generations backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 2 generations backK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- 1 generation backK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013
- This deviceK142368 Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015
- Descendant · cites it directly · 50 of its ownK171048 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 2 generations on · 39 of its ownK173204 RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- Descendant · cites it directly · 32 of its ownK173513 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · Recalled
- Descendant · 2 generations on · 31 of its ownK181336 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- Descendant · 3 generations on · 26 of its ownK182595 HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
Show all 15 generations
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 13 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 12 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 11 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 6 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 5 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
- 3 generations backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 2 generations backK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- 1 generation backK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013
- This deviceK142368 Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · cites it directly50descendants
- K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 2 generations on39descendants
- K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · cites it directly32descendants
- K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 2 generations on31descendants
- K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −14 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −13 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −12 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −11 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −9 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −6 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −5 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K081148 | Siemens Acuson 2000 Ultrasound System with Abvs Transducer | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008 | 3 |
| −3 | K111674 | Acuson | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −2 | K121138 | Acuson S3000 Diagnostic Ultrasound System | Siemens Medical Solution | 2012 | — |
| −1 | K130881 | Acuson S2000 and S3000 | Siemens Medical Solutions USA, Inc. | 2013 | — |
| 0 (this device) | K142368 | Noblus Diagnostic Ultrasound Scanner | Hitachi Aloka Medical, Ltd. | 2015 | — |
| +1 | K171048 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +2 | K173204 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| +1 | K173513 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | 1 |
| +2 | K181336 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| +3 | K182595 | HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 11 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K130308 | Noblus Ultrasound Diagnostic SystemSummary page 4…P P P P P P P Vessel Other (spec.) N = new indication. P = previously cleared in K130308 *Combination of each operating mode, B, M, PWD, CWD and Color Doppler. **Amplitude Doppler (Color Flow Angiography), Ti… | 2013 |
| * | K110673 | HI Vision Ascendus Diagnostic Ultrasound ScannerSummary page 18…Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.) N = new indication. P = previously cleared in K093466, K102901 & K110673 *Combination of each operating mode, B, M, PWD, and Color Doppler. **Amplitude Doppler (Color Flow Angiography), 3D Ima… | 2011 |
| * | K130881 | Acuson S2000 and S3000Summary page 45…Hitachi Noblus™ Diagnostic Ultrasound System [K130308] HI VISION ASCENDUS Diagnostic Ultrasound Scanner [K110673] Siemens Medical Solutions USA, Inc. [K130881] Hudson 2060 Ultrasound Scanner [K022928] 4. Device Description: An ultrasound diagnostic system with the follo… | 2013 |
| * | K022928 | Hudson 2020, 2040, 2060,Ultrasound ScannersSummary page 45…K130308] HI VISION ASCENDUS Diagnostic Ultrasound Scanner [K110673] Siemens Medical Solutions USA, Inc. [K130881] Hudson 2060 Ultrasound Scanner [K022928] 4. Device Description: An ultrasound diagnostic system with the following features: o Ultrasound transduce… | 2002 |
What descends from it? (58)
See all 587 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171048 | RS80A Diagnostic Ultrasound System | 2017 | 50 |
| K173513 | WS80A Diagnostic Ultrasound System | 2018 | 32 |
| K162065 | Ultrasound System SONIMAGE HS1 | 2016 | 2 |
| K162902 | ARIETTA Prologue Diagnostic Ultrasound system and Transducers | 2016 | 0 |
| K160559 | NOBLUS™ Ultrasound Diagnostic System | 2016 | 0 |
| K152126 | Ust-5550-R; Ust-5536-R; L43K | 2016 | 0 |
| K153421 | HI Vision Ascendus, HV Ascendus, Ascendus | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 31, 2020 | Class II | Z-1341-2020 | Process change control | These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 25 of the 93 ancestors have a recall of any class.
- Of its descendants, K171048 (Samsung Medison Co., Ltd., 2017) has gone furthest, with 50 descendants of its own.
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. 2015, 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 Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative (Spec.), Trans-esophageal (Cardiac, Non- Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biospy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult…
Read the full statement (106 words)
The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.)
for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative (Spec.), Trans-esophageal (Cardiac, Non-
Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biospy,
Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-
luminal, Gynecology, Urology, and Laparoscopic clinical applications.
The modes of operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse
Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography),
TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging and Real Time Tissue Elastography.
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/K142368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142368: Noblus Diagnostic Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142368
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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