510(k) · Cleared
ClearedHI Vision Ascendus, HV Ascendus, Ascendus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Aloka Medical America, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 21, 2016 as substantially equivalent to K110673 (Hitachi Medical Systems America, Inc., 2011) and 2 other predicates after a 57-day review. Its family tree reaches back 16 generations to 1995.
- Decided
- Jan 21, 2016
- Review
- 57 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K935595 (1995). 94 ancestors in all, the oldest K891689 (1989). No later device cites it as a predicate yet.
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations between
- 3 generations backK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- 2 generations backK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013
- 1 generation backK142368 Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015 · Recalled
- This deviceK153421 HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc. · 2016
Show all 16 generations
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 14 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 13 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 12 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 11 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 10 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 7 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 6 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
- 4 generations backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 3 generations backK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- 2 generations backK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013
- 1 generation backK142368 Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015 · Recalled
- This deviceK153421 HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −15 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −14 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −13 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −12 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −11 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −10 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −7 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −6 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K081148 | Siemens Acuson 2000 Ultrasound System with Abvs Transducer | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008 | 3 |
| −4 | K111674 | Acuson | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −3 | K121138 | Acuson S3000 Diagnostic Ultrasound System | Siemens Medical Solution | 2012 | — |
| −2 | K130881 | Acuson S2000 and S3000 | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −1 | K142368 | Noblus Diagnostic Ultrasound Scanner | Hitachi Aloka Medical, Ltd. | 2015 | 1 |
| 0 (this device) | K153421 | HI Vision Ascendus, HV Ascendus, Ascendus | Hitachi Aloka Medical America, Inc. | 2016 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K110673 | HI Vision Ascendus Diagnostic Ultrasound ScannerSummary page 4…P P P P P P Other (Spec.) N= new indication P= previously cleared in K110673 *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM- B/C… | 2011 |
| * | K142368 | Noblus Diagnostic Ultrasound ScannerSummary page 47…90-ITX 892.1570 Diagnostic Ultrasound Transducer 3. Legally Marketed Predicate Device(s): HI VISION Ascendus (K110673) Noblus (K142368) Siemens Acuson S2000/S3000 (K130881) 4. Device Description: An ultrasound diagnostic system with the following… | 2015 |
| * | K130881 | Acuson S2000 and S3000Summary page 47…nostic Ultrasound Transducer 3. Legally Marketed Predicate Device(s): HI VISION Ascendus (K110673) Noblus (K142368) Siemens Acuson S2000/S3000 (K130881) 4. Device Description: An ultrasound diagnostic system with the following features: o Ultrasound transduce… | 2013 |
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 21 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 26 of the 94 ancestors have a recall of any class.
- 2 other devices also cite its predicate K110673.
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. 2016, 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?
HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac, Non-Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic…
Read the full statement (107 words)
HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound
evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac, Non-Cardiac) - Adult/Pediatric, Fetal,
Pediatric, Small Organ, Peripheral vessel, Biopsy, 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 HI VISION Ascendus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode
(Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow
Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153421: HI Vision Ascendus, HV Ascendus, Ascendus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153421
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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