510(k) Report

510(k) · Cleared

Cleared

Harmonic Imaging with Contrast

K973767510(k) TraditionalCleared Dec 23, 199782-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

Acuson Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Dec 23, 1997 as substantially equivalent to K935595 (Acuson Corp., 1995) after an 82-day review. Its family tree reaches back 1 generation to 1995. 2 of the 1,089 devices in its family, counting itself, have a Class I recall. 1,087 later devices descend from it.

Decided
Dec 23, 1997
Review
82 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K935595 (1995). 1,087 later devices descend from it, 8 citing it directly. 2 of the 1,089 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2005: 13 descendants cleared2006: 12 descendants cleared1999: 3 descendants cleared1998: 2 descendants cleared2002: 2 descendants cleared2004: 11 descendants cleared2009: 23 descendants cleared2011: 35 descendants cleared2008: 21 descendants cleared2003: 3 descendants cleared2010: 24 descendants cleared2012: 41 descendants cleared2007: 18 descendants cleared2014: 54 descendants cleared2013: 45 descendants cleared2018: 70 descendants cleared2015: 60 descendants cleared2019: 51 descendants cleared2017: 78 descendants cleared2016: 63 descendants cleared2020: 77 descendants cleared2022: 61 descendants cleared2026: 55 descendants cleared2021: 56 descendants cleared2024: 66 descendants cleared2025: 84 descendants cleared, 2 with a Class I recall22023: 59 descendants clearedK935595 · Acuson Model 3001 · Acuson Corp. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 22 descendants3 generations forward: 56 descendants4 generations forward: 99 descendants5 generations forward: 101 descendants6 generations forward: 122 descendants7 generations forward: 153 descendants8 generations forward: 148 descendants9 generations forward: 127 descendants, 2 with a Class I recall210 generations forward: 90 descendants11 generations forward: 59 descendants12 generations forward: 48 descendants13 generations forward: 27 descendants14 generations forward: 16 descendants15 generations forward: 7 descendants16 generations forward: 3 descendants17 generations forward: 1 descendant K935595 · Acuson Model 3001 · Acuson Corp. · 19950+5+10+15
  1. Root · 1 generation backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. This deviceK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
  3. Descendant · cites it directly · 1,069 of its ownK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  4. Descendant · 2 generations on · 1,003 of its ownK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
  5. Descendant · 3 generations on · 988 of its ownK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
  6. Descendant · 4 generations on · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
  7. Descendant · 5 generations on · 972 of its ownK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005

Showing 5 of 1,087 descendants. See all descendants

Descendants cleared per year

1998: 21999: 32002: 22003: 32004: 112005: 132006: 122007: 182008: 212009: 232010: 242011: 352012: 412013: 452014: 542015: 602016: 632017: 782018: 702019: 512020: 772021: 562022: 612023: 592024: 662025: 842026: 55
1998high 84 (2025) · low 0 (2000)2026

Class I recalls in this family

  • K242670 Lumify Diagnostic Ultrasound System9 generations on · 2025
  • K242519 Lumify Diagnostic Ultrasound System9 generations on · 2025

Most influential descendants

Showing 5 of 1,087 · See all
  • K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002 · cites it directly1,069descendants
  • K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on1,003descendants
  • K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on988descendants
  • K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 4 generations on979descendants
  • K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 5 generations on972descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K935595Acuson Model 3001Acuson Corp.1995—
0 (this device)K973767Harmonic Imaging with ContrastAcuson Corp.1997—
+1K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.2002—
+2K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2003—
+3K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004—
+4K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005—
+5K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199930
200220
200330
2004110
2005130
2006120
2007180
2008210
2009230
2010240
2011350
2012410
2013450
2014540
2015600
2016630
2017780
2018700
2019510
2020770
2021560
2022610
2023590
2024660
2025842
2026550
FIG. 1 — Lineage of K973767, 1995–2026Source: 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), 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 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K935595Acuson Model 3001
Summary page 1
…DEVICE DESCRIPTION The Sequoia™ Ultrasound System with the Harmonic Imaging with Contrast utilizes the previously cleared Sequoia™ Ultrasound system (Acuson Model 3001- K935595/S1) and its transcutaneous as well as invasive transducers to create 2-D, M-mode, color Doppler and Spectral Doppler displays of…
Acuson Corp.1995—

Also cleared against K935595: 1 other device →

What descends from it? (1,087)

See all 1,087

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

NumberDeviceApplicantDecidedDescendants
K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.20021,069
K020630Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation2002595
K042326Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation2004590
K061827Sonix Ultrasound ScannerUltrasonix Medical Corporation2006586
K990339Sonos 5500 Imaging System M2424A Version B.OHewlett-Packard Co.1999189
K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2005167
K981528Sonoline Elegra Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.19981
K980687Sonos 5500 Ultrasound Imaging SystemHewlett-Packard Co.19981

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 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
  • K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K022567 (Acuson Corp., 2002) has gone furthest, with 1,069 descendants of its own.
  • 1 other device also cites its predicate K935595.

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—

What is it indicated for?

The Sequoia™ Ultrasound System is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved.” The TE-V5M transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™. The 8LS transducer is intended for Harmonic Imaging and…

Read the full statement (380 words)

The Sequoia™ Ultrasound System is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved.”

The TE-V5M transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™.

The 8LS transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™.

The 6L3 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™.

The 15L8 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™.

The 8V transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™.

The 7V3c transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”.

The 5V2c transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”.

The 3V2c transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”.

The 8C4 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”.

The 5C2 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”.

The 4V2 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved™.

The EV-8C4 transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”.

The Aux CW transducer is intended for Harmonic Imaging and Conventional Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved”.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K935595

1 other device cites the same predicate.

  • K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002

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
  • K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  • K021497Cypress Ultrasound SystemAcuson Corp. · 20022 recalls
  • K010950Cypress SystemAcuson Corp. · 2001

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https://510kreport.com/device/K973767 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973767: Harmonic Imaging with Contrast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973767

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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