510(k) Report

510(k) · Cleared

Cleared

3D Organ Assessment W/ Magnetic Position Sensing

K002807510(k) TraditionalCleared Dec 1, 200084-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 1, 2000 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 1,073 devices in its family, counting itself, have a Class I recall. 1,072 later devices descend from it.

Decided
Dec 1, 2000
Review
84 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

1,072 later devices descend from it, 2 citing it directly. 2 of the 1,073 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2014: 55 descendants cleared2002: 1 descendant cleared2004: 10 descendants cleared2011: 34 descendants cleared2008: 19 descendants cleared2006: 11 descendants cleared2003: 3 descendants cleared2010: 23 descendants cleared2021: 57 descendants cleared2019: 50 descendants cleared2007: 17 descendants cleared2009: 22 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 cleared2025: 84 descendants cleared, 2 with a Class I recall22023: 59 descendants cleared2024: 66 descendants cleared200020052010201520202025
  1. This deviceK002807 3D Organ Assessment W/ Magnetic Position SensingAcuson Corp. · 2000
  2. Descendant · cites it directly · 1,069 of its ownK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  3. Descendant · 2 generations on · 1,003 of its ownK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
  4. Descendant · 3 generations on · 988 of its ownK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
  5. Descendant · 4 generations on · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
  6. Descendant · 5 generations on · 972 of its ownK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005

Showing 5 of 1,072 descendants. See all descendants

Descendants cleared per year

2002: 12003: 32004: 102005: 132006: 112007: 172008: 192009: 222010: 232011: 342012: 402013: 452014: 552015: 602016: 632017: 782018: 692019: 502020: 772021: 572022: 612023: 592024: 662025: 842026: 55
2002high 84 (2025) · low 1 (2002)2026

Class I recalls in this family

  • K242670 Lumify Diagnostic Ultrasound System12 generations on · 2025
  • K242519 Lumify Diagnostic Ultrasound System12 generations on · 2025

Most influential descendants

Showing 5 of 1,072 · 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
0 (this device)K0028073D Organ Assessment W/ Magnetic Position SensingAcuson Corp.2000—
+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
200210
200330
2004100
2005130
2006110
2007170
2008190
2009220
2010230
2011340
2012400
2013450
2014550
2015600
2016630
2017780
2018690
2019500
2020770
2021570
2022610
2023590
2024660
2025842
2026550
FIG. 1 — Lineage of K002807, 2000–2026Source: 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? (1,072)

See all 1,072

2 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
K141870Breast Volume NavigatorMetritrack, LLC20142

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 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
  • K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K022567 (Acuson Corp., 2002) has gone furthest, with 1,069 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 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

Recent decisions in IYO

The IYO category page

  • K262093Accuro XVRivanna Medical, Inc. · 2026
  • K260605Lilium one (USM330)Lilium Otsuka Co., Ltd. · 2026
  • K260313MD-6000S Bladder ScannerMEDA Co., Ltd. · 2026
  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K260190ArthurROPCA ApS · 2026

https://510kreport.com/device/K002807 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002807: 3D Organ Assessment W/ Magnetic Position Sensing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002807

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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