510(k) Report

510(k) · Cleared

Cleared

Sequoia Signature II Diagnostic Ultrasound System

K022567510(k) TraditionalCleared Aug 13, 200211-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

Acuson Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Aug 13, 2002 as substantially equivalent to K935595 (Acuson Corp., 1995) and 6 other predicates after an 11-day review. Its family tree reaches back 2 generations to 1995. 2 of the 1,081 devices in its family, counting itself, have a Class I recall. 1,069 later devices descend from it.

Decided
Aug 13, 2002
Review
11 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K935595 (1995). 11 ancestors in all, the oldest K921148 (1992). 1,069 later devices descend from it, 10 citing it directly. 2 of the 1,081 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1999: 3 other ancestors1997: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestor2004: 10 descendants cleared2011: 34 descendants cleared2008: 19 descendants cleared2006: 11 descendants cleared2003: 3 descendants cleared2010: 23 descendants cleared2007: 17 descendants cleared2009: 22 descendants cleared2014: 54 descendants cleared2012: 40 descendants cleared2015: 60 descendants cleared2016: 63 descendants cleared2018: 69 descendants cleared2005: 13 descendants cleared2013: 45 descendants cleared2017: 78 descendants cleared2022: 61 descendants cleared2020: 77 descendants cleared2026: 55 descendants cleared2019: 50 descendants cleared2025: 84 descendants cleared, 2 with a Class I recall22021: 56 descendants cleared2023: 59 descendants cleared2024: 66 descendants clearedK935595 · Acuson Model 3001 · Acuson Corp. · 1995K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 4 other ancestors 1 generation forward: 10 descendants2 generations forward: 30 descendants3 generations forward: 56 descendants4 generations forward: 59 descendants5 generations forward: 76 descendants6 generations forward: 114 descendants7 generations forward: 136 descendants8 generations forward: 136 descendants9 generations forward: 112 descendants10 generations forward: 100 descendants11 generations forward: 83 descendants, 2 with a Class I recall212 generations forward: 61 descendants13 generations forward: 35 descendants14 generations forward: 28 descendants15 generations forward: 16 descendants16 generations forward: 10 descendants17 generations forward: 5 descendants18 generations forward: 2 descendants K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K935595 · Acuson Model 3001 · Acuson Corp. · 19950+5+10+15
  1. Root · 2 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 1 generation backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
  3. This deviceK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  4. Descendant · cites it directly · 1,003 of its ownK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
  5. Descendant · 2 generations on · 988 of its ownK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
  6. Descendant · 3 generations on · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
  7. Descendant · 4 generations on · 972 of its ownK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
  8. Descendant · cites it directly · 955 of its ownK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled

Showing 5 of 1,069 descendants. See all descendants

Descendants cleared per year

2003: 32004: 102005: 132006: 112007: 172008: 192009: 222010: 232011: 342012: 402013: 452014: 542015: 602016: 632017: 782018: 692019: 502020: 772021: 562022: 612023: 592024: 662025: 842026: 55
2003high 84 (2025) · low 3 (2003)2026

Class I recalls in this family

  • K242670 Lumify Diagnostic Ultrasound System11 generations on · 2025
  • K242519 Lumify Diagnostic Ultrasound System11 generations on · 2025

Most influential descendants

Showing 5 of 1,069 · See all
  • K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003 · cites it directly1,003descendants
  • K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on988descendants
  • K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 3 generations on979descendants
  • K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 4 generations on972descendants
  • K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · cites it directly955descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K935595Acuson Model 3001Acuson Corp.1995—
−1K973767Harmonic Imaging with ContrastAcuson Corp.1997—
0 (this device)K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.2002—
+1K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2003—
+2K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004—
+3K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005—
+4K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.2005—
+1K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20031

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410
199510
199710
199930
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200330
2004100
2005130
2006110
2007170
2008190
2009220
2010230
2011340
2012400
2013450
2014540
2015600
2016630
2017780
2018690
2019500
2020770
2021560
2022610
2023590
2024660
2025842
2026550
FIG. 1 — Lineage of K022567, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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.

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 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? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K935595Acuson Model 3001
Summary page 2
…ices in the heart - for use in the right heart only. 6. Technological Comparison to Predicate Device: The Sequoia is substantially equivalent to Model 3001,K935595/Sl/Sl, and to products that are already cleared for USA distribution with the following 51 O(k) premarket notification…
Acuson Corp.1995—
*K973767Harmonic Imaging with Contrast
Summary page 2
…t to Model 3001,K935595/Sl/Sl, and to products that are already cleared for USA distribution with the following 51 O(k) premarket notification numbers K973767,K992580,K992631, K002807,K991805,and K002470. All systems transmit ultrasonic energy into patients, then perform post pro…
Acuson Corp.1997—
*K992580Fetal Assessment Cap
Summary page 2
…el 3001,K935595/Sl/Sl, and to products that are already cleared for USA distribution with the following 51 O(k) premarket notification numbers K973767,K992580,K992631, K002807,K991805,and K002470. All systems transmit ultrasonic energy into patients, then perform post processing…
Acuson Corp.1999—
*K992631Acunav Diagnostic Ultrasound Catheter
Summary page 2
…K935595/Sl/Sl, and to products that are already cleared for USA distribution with the following 51 O(k) premarket notification numbers K973767,K992580,K992631, K002807,K991805,and K002470. All systems transmit ultrasonic energy into patients, then perform post processing of recei…
Acuson Corp.19991
*K0028073D Organ Assessment W/ Magnetic Position Sensing
Summary page 2
…l/Sl, and to products that are already cleared for USA distribution with the following 51 O(k) premarket notification numbers K973767,K992580,K992631, K002807,K991805,and K002470. All systems transmit ultrasonic energy into patients, then perform post processing of received echoe…
Acuson Corp.2000—
*K991805Aspen Ultrasound with Freestyle Imaging Option
Summary page 2
…and to products that are already cleared for USA distribution with the following 51 O(k) premarket notification numbers K973767,K992580,K992631, K002807,K991805,and K002470. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to gen…
Acuson Corp.19991
*K002470M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A Transducer
Summary page 2
…ucts that are already cleared for USA distribution with the following 51 O(k) premarket notification numbers K973767,K992580,K992631, K002807,K991805,and K002470. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-scr…
Agilent Technologies, Inc.2000—

Also cleared against K935595: 1 other device →

What descends from it? (1,069)

See all 1,069

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

NumberDeviceApplicantDecidedDescendants
K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20031,003
K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.2003955
K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209
K040546Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH2004184
K060992Syngo US WorkplaceSiemens Medical Solutions200697
K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp.200884
K100598Penrith Elettra Ultrasound SystemPenrith Corporation201064
K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662
K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112
K100363Ultra Dci Model 5000Ultrasound Medical Devices, Inc.20100

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

What does this lineage say?

  • The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 4.6 years on median.
  • 2 of the 11 ancestors have a recall of any class.
  • Of its descendants, K032114 (Siemens Medical Solutions USA, Inc., 2003) has gone furthest, with 1,003 descendants of its own.
  • 1 other device also cites its predicate K935595.

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)—

What is it indicated for?

The Sequoia system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), NeonataVAdult Cephalic, Cardiac (adult and pediatric), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (Superficial and Conventional) applications. The system also provides for the…

Read the full statement (106 words)

The Sequoia system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), NeonataVAdult Cephalic, Cardiac (adult and pediatric), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (Superficial and Conventional) applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The AcuNav diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.

Indications for use as stated in the FDA summary.

Also cleared against K935595

1 other device cites the same predicate.

  • K973767Harmonic Imaging with ContrastAcuson Corp. · 1997

More from Acuson Corp.

37 FDA decisions under this applicant name. See the company

  • K023772Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 20025 recalls
  • K022896CSV12 Software ViewerAcuson Corp. · 2002
  • K021497Cypress Ultrasound SystemAcuson Corp. · 20022 recalls
  • K010950Cypress SystemAcuson Corp. · 2001
  • K0028073D Organ Assessment W/ Magnetic Position SensingAcuson Corp. · 2000

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/K022567 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022567: Sequoia Signature II Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022567

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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