510(k) Report

510(k) · Cleared

Cleared

Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe System

K011252510(k) TraditionalCleared May 30, 200136-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hitachi Medical Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on May 30, 2001 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 814 devices in its family, counting itself, have a Class I recall. 813 later devices descend from it.

Decided
May 30, 2001
Review
36 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

813 later devices descend from it, 3 citing it directly. 2 of the 814 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2001: 1 descendant cleared2006: 1 descendant cleared2007: 3 descendants cleared2012: 28 descendants cleared2011: 19 descendants cleared2016: 59 descendants cleared2018: 62 descendants cleared2008: 3 descendants cleared2013: 32 descendants cleared2009: 5 descendants cleared2010: 9 descendants cleared2014: 45 descendants cleared2020: 64 descendants cleared2019: 47 descendants cleared2015: 49 descendants cleared2017: 69 descendants cleared2022: 54 descendants cleared2023: 50 descendants cleared2024: 54 descendants cleared2021: 48 descendants cleared2025: 65 descendants cleared, 2 with a Class I recall22026: 46 descendants cleared200020052010201520202025
  1. This deviceK011252 Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe SystemHitachi Medical Corp. · 2001
  2. Descendant · cites it directly · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
  3. Descendant · 2 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
  4. Descendant · 3 generations on · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
  5. Descendant · 4 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
  6. Descendant · 4 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008

Showing 5 of 813 descendants. See all descendants

Descendants cleared per year

2001: 12006: 12007: 32008: 32009: 52010: 92011: 192012: 282013: 322014: 452015: 492016: 592017: 692018: 622019: 472020: 642021: 482022: 542023: 502024: 542025: 652026: 46
2001high 69 (2017) · low 0 (2002)2026

Class I recalls in this family

  • K242670 Lumify Diagnostic Ultrasound System10 generations on · 2025
  • K242519 Lumify Diagnostic Ultrasound System10 generations on · 2025

Most influential descendants

Showing 5 of 813 · See all
  • K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · cites it directly802descendants
  • K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 2 generations on801descendants
  • K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on800descendants
  • K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 4 generations on588descendants
  • K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 4 generations on582descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011252Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe SystemHitachi Medical Corp.2001—
+1K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006—
+2K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20079
+3K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007—
+4K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20102
+4K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200610
200730
200830
200950
201090
2011190
2012280
2013320
2014450
2015490
2016590
2017690
2018620
2019470
2020640
2021480
2022540
2023500
2024540
2025652
2026460
FIG. 1 — Lineage of K011252, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. 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. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (813)

See all 813

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802
K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc.20078
K012239Modifications to Eub-525 Diagnostic Ultrasound Scanner; Eub-2000 Diagnostic Ultrasound…Hitachi Medical Corp.20010

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
  • K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K063138 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 802 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

More from Hitachi Medical Corp.

11 FDA decisions under this applicant name. See the company

  • K073310Oasis CTL Coil, OD Flexible Body Coil (L and XL), and Rapid Foot CoilHitachi Medical Corp. · 2008
  • K061608Modification to Eub-5500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2006
  • K053258Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2005
  • K042501Etg-4000 Optical Topography SystemHitachi Medical Corp. · 2004
  • K013722Modification to: Eub-8500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 20021 recall

Recent decisions in IYO

The IYO category page

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https://510kreport.com/device/K011252 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011252: Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011252

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026