510(k) · Cleared
Recalled · Class II · 2021Aloka Arietta 850
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Healthcare Americas Corporation · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 28, 2018 as substantially equivalent to K171708 (Hitachi Healthcare Americas Corporation, 2017) after an 83-day review. Its family tree reaches back 15 generations to 1995. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 28, 2018
- Review
- 83 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 15 generations to K935595 (1995). 81 ancestors in all, the oldest K891689 (1989). 7 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations between
- 3 generations backK110673 HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc. · 2011
- 2 generations backK134016 Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · 2014 · Recalled
- 1 generation backK171708 Aloka Arietta 850Hitachi Healthcare Americas Corporation · 2017 · Recalled
- This deviceK173739 Aloka Arietta 850Hitachi Healthcare Americas Corporation · 2018
- Descendant · cites it directly · 3 of its ownK181376 Arietta 65Hitachi Healthcare Americas Corporation · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK183456 Aloka Arietta 850Hitachi Healthcare Americas · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK190248 Arietta 50Hitachi Healthcare Americas · 2019
- Descendant · 2 generations on · 0 of its ownK231941 ARIETTA x10FUJIFILM Healthcare Americas Corporation · 2023
- Descendant · 3 generations on · 0 of its ownK220295 Arietta 50Fujifilm Healthcare Corporation · 2022
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 backK093466 HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision…Hitachi Medical Systems America, Inc. · 2010 · Recalled
- 3 generations backK110673 HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc. · 2011
- 2 generations backK134016 Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · 2014 · Recalled
- 1 generation backK171708 Aloka Arietta 850Hitachi Healthcare Americas Corporation · 2017 · Recalled
- This deviceK173739 Aloka Arietta 850Hitachi Healthcare Americas Corporation · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K181376Arietta 65Hitachi Healthcare Americas Corporation · 2018 · cites it directly3descendants
- K183456Aloka Arietta 850Hitachi Healthcare Americas · 2019 · cites it directly2descendants
- K190248Arietta 50Hitachi Healthcare Americas · 2019 · 2 generations on1descendant
- K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation · 2023 · 2 generations on0descendants
- K220295Arietta 50Fujifilm Healthcare Corporation · 2022 · 3 generations on0descendants
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 | K093466 | HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus | Hitachi Medical Systems America, Inc. | 2010 | 1 |
| −3 | K110673 | HI Vision Ascendus Diagnostic Ultrasound Scanner | Hitachi Medical Systems America, Inc. | 2011 | — |
| −2 | K134016 | Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2014 | 2 |
| −1 | K171708 | Aloka Arietta 850 | Hitachi Healthcare Americas Corporation | 2017 | 1 |
| 0 (this device) | K173739 | Aloka Arietta 850 | Hitachi Healthcare Americas Corporation | 2018 | — |
| +1 | K181376 | Arietta 65 | Hitachi Healthcare Americas Corporation | 2018 | 1 |
| +1 | K183456 | Aloka Arietta 850 | Hitachi Healthcare Americas | 2019 | 3 |
| +2 | K190248 | Arietta 50 | Hitachi Healthcare Americas | 2019 | — |
| +2 | K231941 | ARIETTA x10 | FUJIFILM Healthcare Americas Corporation | 2023 | — |
| +3 | K220295 | Arietta 50 | Fujifilm Healthcare Corporation | 2022 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K171708 | Aloka Arietta 850Summary page 4…ral Vessel Peripheral vessel P P P P P P P N = new indication; P = previously cleared in K171708, K140639 *Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-… | 2017 |
| † | K140639 | Prosound F75 Diagnostic Ultrasound System | 2014 |
What descends from it? (7)
2 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 |
|---|---|---|---|---|
| Oct 14, 2021 | Class II | Z-0190-2022 | Software design | Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral… |
| Jun 30, 2021 | Class II | Z-2308-2021 | Under Investigation by firm | The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 20 of the 81 ancestors have a recall of any class.
- Of its descendants, K181376 (Hitachi Healthcare Americas Corporation, 2018) has gone furthest, with 3 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. 2018, 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 ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.)…
Read the full statement (91 words)
The ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, Sonographer, etc.) for the
diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ
(Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.),
Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology,
Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, and gastro-intestinal (GI) endoscopic
clinical applications.
The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous
Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging),
3D Imaging, 4D Imaging.
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/K173739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173739: Aloka Arietta 850.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173739
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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