510(k) · Cleared
Recalled · Class II · 2020Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 28, 2014 as substantially equivalent to K110673 (Hitachi Medical Systems America, Inc., 2011) and 1 other predicate after an 88-day review. Its family tree reaches back 13 generations to 1995. 25 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 28, 2014
- Review
- 88 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 13 generations to K935595 (1995). 79 ancestors in all, the oldest K891689 (1989). 25 later devices descend from it, 6 citing it directly.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK093466 HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision…Hitachi Medical Systems America, Inc. · 2010 · Recalled
- 1 generation backK110673 HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc. · 2011
- This deviceK134016 Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · 2014
- Descendant · cites it directly · 12 of its ownK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
- Descendant · cites it directly · 9 of its ownK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
- Descendant · cites it directly · 8 of its ownK171708 Aloka Arietta 850Hitachi Healthcare Americas Corporation · 2017 · Recalled
- Descendant · 2 generations on · 7 of its ownK173739 Aloka Arietta 850Hitachi Healthcare Americas Corporation · 2018 · Recalled
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 4 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 3 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK093466 HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision…Hitachi Medical Systems America, Inc. · 2010 · Recalled
- 1 generation backK110673 HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc. · 2011
- This deviceK134016 Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016 · cites it directly12descendants
- K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · cites it directly9descendants
- K1732916440 Ultrasound SystemEsaote, S.p.A. · 2018 · 2 generations on8descendants
- K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation · 2017 · cites it directly8descendants
- K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation · 2018 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −7 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −4 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −3 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K093466 | HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus | Hitachi Medical Systems America, Inc. | 2010 | 1 |
| −1 | K110673 | HI Vision Ascendus Diagnostic Ultrasound Scanner | Hitachi Medical Systems America, Inc. | 2011 | — |
| 0 (this device) | K134016 | Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2014 | — |
| +1 | K153277 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2016 | — |
| +1 | K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2017 | 2 |
| +2 | K173291 | 6440 Ultrasound System | Esaote, S.p.A. | 2018 | — |
| +1 | K171708 | Aloka Arietta 850 | Hitachi Healthcare Americas Corporation | 2017 | 1 |
| +2 | K173739 | Aloka Arietta 850 | Hitachi Healthcare Americas Corporation | 2018 | 2 |
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 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (2)
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 2…Arietta 70*! AscenduA S K 123828 Arietta S701/ K 110673 Function Arietta \V70* Color Flow… | 2011 |
| * | K123828 | Prosound F75 Diagnostic Ultrasound SystemSummary page 1…rketed predicate Device(s): Hlitachi HIl VISION Ascendus Diagnostic Ultrasound Scanner [K! 1067311 Hlitachi Prosound F75 Diagnostic Ultrasound Scanner [K 123828] 4. Device Description: An ultrasound diagnostic system Nvith the folowying leatUres: " Ultrasound tra… | 2013 |
What descends from it? (25)
See all 256 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 |
|---|---|---|---|---|
| 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. |
| May 2, 2017 | Class II | Z-2090-2017 | Device Design | The strength of the arm mounting mechanism was insufficient and had to be redesigned. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 18 of the 79 ancestors have a recall of any class.
- Of its descendants, K153277 (Esaote, S.p.A., 2016) has gone furthest, with 12 descendants of its own.
- 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. 2014, 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 Aloka Medical, Ltd. Arietta70/ AriettaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. The Modes of…
Read the full statement (92 words)
The Hitachi Aloka Medical, Ltd. Arietta70/ AriettaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
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/K134016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134016: Arietta 70/Arietta S70/Arietta V70 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/K134016
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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