510(k) · Cleared
Recalled · 2011HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 17, 2010 as substantially equivalent to K063518 (Hitachi Medical Systems America, Inc., 2006) and 2 other predicates after a 223-day review. Its family tree reaches back 11 generations to 1995. 96 later devices descend from it. It has been recalled once.
- Decided
- Jun 17, 2010
- Review
- 223 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 11 generations to K935595 (1995). 66 ancestors in all, the oldest K891689 (1989). 96 later devices descend from it, 6 citing it directly.
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations between
- 3 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 2 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- This deviceK093466 HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision…Hitachi Medical Systems America, Inc. · 2010
- Descendant · cites it directly · 85 of its ownK110673 HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc. · 2011
- Descendant · cites it directly · 60 of its ownK102901 HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 59 of its ownK130308 Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd. · 2013
- Descendant · 2 generations on · 58 of its ownK142368 Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015 · Recalled
- Descendant · 3 generations on · 50 of its ownK171048 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
Show all 11 generations
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 9 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 8 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 7 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 3 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 2 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- This deviceK093466 HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision…Hitachi Medical Systems America, Inc. · 2010
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 96 · See all- K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc. · 2011 · cites it directly85descendants
- K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc. · 2010 · cites it directly60descendants
- K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd. · 2013 · 2 generations on59descendants
- K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015 · 2 generations on58descendants
- K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on50descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −10 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −9 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −8 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −7 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −5 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −3 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −2 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −1 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| 0 (this device) | K093466 | HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus | Hitachi Medical Systems America, Inc. | 2010 | — |
| +1 | K110673 | HI Vision Ascendus Diagnostic Ultrasound Scanner | Hitachi Medical Systems America, Inc. | 2011 | — |
| +1 | K102901 | HI Vision Avius Diagnostic Ultrasound Scanner | Hitachi Medical Systems America, Inc. | 2010 | 1 |
| +2 | K130308 | Noblus Ultrasound Diagnostic System | Hitachi Aloka Medical, Ltd. | 2013 | — |
| +2 | K142368 | Noblus Diagnostic Ultrasound Scanner | Hitachi Aloka Medical, Ltd. | 2015 | 1 |
| +3 | K171048 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
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 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K063518 | HI Vision 900 Diagnostic Ultrasound ScannerSummary page 1…Proprietary Name: HITACHI Hi VISION Preirus Diagnostic Ultrasound Scanner Predicate Device(s): Hi VISION 900 Diagnostic Ultrasound Scanner (K063518) GE Logiq® E9 (K0821 85) ___________________Acuson S2000 (K072786) Dev… | 2006 |
| * | K082185 | GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Summary page 1…nostic Ultrasound Scanner Predicate Device(s): Hi VISION 900 Diagnostic Ultrasound Scanner (K063518) GE Logiq® E9 (K0821 85) ___________________Acuson S2000 (K072786) Device Intended Use The HI VISION Preirus is intended for use by… | 2008 |
| * | K072786 | Acuson S2000 Ultrasound SystemSummary page 1…Hi VISION 900 Diagnostic Ultrasound Scanner (K063518) GE Logiq® E9 (K0821 85) ___________________Acuson S2000 (K072786) Device Intended Use The HI VISION Preirus is intended for use by trained personnel (doctor, songrapher, etc.) for the diagnosti… | 2007 |
What descends from it? (96)
See all 966 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110673 | HI Vision Ascendus Diagnostic Ultrasound Scanner | 2011 | 85 |
| K102901 | HI Vision Avius Diagnostic Ultrasound Scanner | 2010 | 60 |
| K153277 | 6200 Ultrasound System and 6250 Ultrasound System | 2016 | 12 |
| K121564 | Endoscopic Ultrasound Center EU-Y0006 | 2012 | 6 |
| K130058 | Endoscopic Ultrasound Center EU-Y0008 | 2013 | 4 |
| K111142 | Echosoft (TM) | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 18, 2011 | Not classified | Z-2467-2011 | Software design | Software anomaly. The Doppler Trace Measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. The… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 16 of the 66 ancestors have a recall of any class.
- Of its descendants, K110673 (Hitachi Medical Systems America, Inc., 2011) has gone furthest, with 85 descendants of its own.
- 4 other devices also cite its predicate K063518.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Hi VISION Preirus isintended for use by trained personnel (doctor, songrapher, 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 Lapanoscopic clinical applications. The Modesof Operation of the HI VISION Preirus are Bmode…
Read the full statement (89 words)
The Hi VISION Preirus isintended for use by trained personnel (doctor, songrapher, 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 Lapanoscopic clinical applications.
The Modesof Operation of the HI VISION Preirus are Bmode, Mmode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 40 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/K093466 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093466: HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093466
Report an extraction error
Are you the manufacturer?
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