510(k) Report

510(k) · Cleared

Cleared

Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability

K011224510(k) TraditionalCleared May 4, 200114-day reviewClass II21 CFR 892.1550

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

Advanced Technology Laboratories, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on May 4, 2001 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 691 later devices descend from it.

Decided
May 4, 2001
Review
14 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
0

691 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2008: 5 descendants cleared2002: 1 descendant cleared2004: 1 descendant cleared2009: 5 descendants cleared2005: 3 descendants cleared2003: 2 descendants cleared2006: 2 descendants cleared2007: 2 descendants cleared2010: 8 descendants cleared2014: 39 descendants cleared2011: 14 descendants cleared2012: 25 descendants cleared2015: 38 descendants cleared2013: 25 descendants cleared2017: 54 descendants cleared2019: 41 descendants cleared2016: 48 descendants cleared2020: 57 descendants cleared2018: 52 descendants cleared2022: 47 descendants cleared2025: 54 descendants cleared2023: 42 descendants cleared2021: 43 descendants cleared2026: 35 descendants cleared2024: 48 descendants cleared200020052010201520202025
  1. This deviceK011224 Hdi 5000 Ultrasound System with Assisted Border Detection (Abd)…Advanced Technology Laboratories, Inc. · 2001
  2. Descendant · cites it directly · 683 of its ownK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
  3. Descendant · cites it directly · 678 of its ownK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
  4. Descendant · cites it directly · 676 of its ownK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
  5. Descendant · 2 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
  6. Descendant · 2 generations on · 583 of its ownK080223 Zura Tee SystemImacor, LLC · 2008 · Recalled

Showing 5 of 691 descendants. See all descendants

Descendants cleared per year

2002: 12003: 22004: 12005: 32006: 22007: 22008: 52009: 52010: 82011: 142012: 252013: 252014: 392015: 382016: 482017: 542018: 522019: 412020: 572021: 432022: 472023: 422024: 482025: 542026: 35
2002high 57 (2020) · low 1 (2002)2026

Most influential descendants

Showing 5 of 691 · See all
  • K030949Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003 · cites it directly683descendants
  • K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · cites it directly678descendants
  • K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · cites it directly676descendants
  • K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 2 generations on584descendants
  • K080223Zura Tee SystemImacor, LLC · 2008 · 2 generations on583descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011224Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging…Advanced Technology Laboratories, Inc.2001—
+1K030949Titan High Resolution Ultrasound SystemSonosite,Inc.2003—
+1K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20054
+1K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20053
+2K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008—
+2K080223Zura Tee SystemImacor, LLC20081

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200410
200530
200620
200720
200850
200950
201080
2011140
2012250
2013250
2014390
2015380
2016480
2017540
2018520
2019410
2020570
2021430
2022470
2023420
2024480
2025540
2026350
FIG. 1 — Lineage of K011224, 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.

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. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (691)

See all 691

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

NumberDeviceApplicantDecidedDescendants
K030949Titan High Resolution Ultrasound SystemSonosite,Inc.2003683
K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.2005678
K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.2005676
K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.2007259
K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.2008247
K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.200927
K043452Titan High Resolution Ultrasound System and Sonosite Ultrasound SystemSonosite,Inc.200411
K053648Pioneer TC8080, Companion IiiViasys Neuro Care20064
K052109Sonosite Hand-Carried Ultrasound System (C1 Series)Sonosite,Inc.20050
K023957Sonosite Hand-Carried Ultrasound System (C2 Series)Sonosite,Inc.20020

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?

  • Of its descendants, K030949 (Sonosite,Inc., 2003) has gone furthest, with 683 descendants of its own.

How does its category compare?

All IYN devices

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

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

More from Advanced Technology Laboratories, Inc.

64 FDA decisions under this applicant name. See the company

  • K021966Q Lab SoftwareAdvanced Technology Laboratories, Inc. · 2002
  • K002144Medlink Diagnostic Offline WorkstationAdvanced Technology Laboratories, Inc. · 2000
  • K992470Ultramark 400C/Sonoace 6000 Ultrasound SystemAdvanced Technology Laboratories, Inc. · 1999
  • K991671Hdi 5000 Diagnostic Ultrasound SystemAdvanced Technology Laboratories, Inc. · 1999
  • P940005/S002Hdi 3000 Ultrasound System with L12-5 ScanheadAdvanced Technology Laboratories, Inc. · 1998

Recent decisions in IYN

The IYN category page

  • K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K011224 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011224: Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011224

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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