510(k) Report

510(k) · Cleared

Cleared

Usi-2000 Ultrasound System with Automated Scanning Accessory

K022517510(k) TraditionalCleared Dec 24, 2002147-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

U-Systems, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Dec 24, 2002 after a 147-day review. The FDA summary names its predicate without a number. 66 later devices descend from it.

Decided
Dec 24, 2002
Review
147 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
0

66 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2005: 1 descendant cleared2008: 3 descendants cleared2007: 1 descendant cleared2014: 2 descendants cleared2013: 1 descendant cleared2022: 5 descendants cleared2026: 7 descendants cleared2009: 1 descendant cleared2017: 5 descendants cleared2021: 4 descendants cleared2019: 4 descendants cleared2016: 2 descendants cleared2018: 6 descendants cleared2015: 1 descendant cleared2020: 6 descendants cleared2023: 5 descendants cleared2025: 5 descendants cleared2024: 6 descendants cleared200020052010201520202025
  1. This deviceK022517 Usi-2000 Ultrasound System with Automated Scanning AccessoryU-Systems, Inc. · 2002
  2. Descendant · cites it directly · 65 of its ownK032640 Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound SystemU-Systems, Inc. · 2003
  3. Descendant · 2 generations on · 64 of its ownK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
  4. Descendant · 2 generations on · 53 of its ownK080555 Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008
  5. Descendant · 3 generations on · 50 of its ownK123209 SoftvueDelphinus Medical Technologies, Inc. · 2013
  6. Descendant · 4 generations on · 49 of its ownK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12007: 12008: 32009: 12013: 12014: 22015: 12016: 22017: 52018: 62019: 42020: 62021: 42022: 52023: 52024: 62025: 52026: 7
2003high 7 (2026) · low 0 (2004)2026

Most influential descendants

Showing 5 of 66 · See all
  • K032640Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound SystemU-Systems, Inc. · 2003 · cites it directly65descendants
  • K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005 · 2 generations on64descendants
  • K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008 · 2 generations on53descendants
  • K123209SoftvueDelphinus Medical Technologies, Inc. · 2013 · 3 generations on50descendants
  • K142517SoftVueDelphinus Medical Technologies, Inc. · 2014 · 4 generations on49descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022517Usi-2000 Ultrasound System with Automated Scanning AccessoryU-Systems, Inc.2002—
+1K032640Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound SystemU-Systems, Inc.2003—
+2K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc.2005—
+2K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation2008—
+3K123209SoftvueDelphinus Medical Technologies, Inc.2013—
+4K142517SoftVueDelphinus Medical Technologies, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200710
200830
200910
201310
201420
201510
201620
201750
201860
201940
202060
202140
202250
202350
202460
202550
202670
FIG. 1 — Lineage of K022517, 2002–2026Source: 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.

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? (2)

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
*—LABSONICS Ultrasound Breast Scanner
Named without a submission number
—
*—Sonopsy LA System
Named without a submission number
—

What descends from it? (66)

See all 66

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032640Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound SystemU-Systems, Inc.200365

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, K032640 (U-Systems, Inc., 2003) has gone furthest, with 65 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)—

What is it indicated for?

The USI-2000 Diagnostic Ultrasound System is being modified to include an accessory for use with the existing diagnostic ultrasound system. The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient’s breast when used with an automatic scanning linear array transducer. Imaging is based on B-mode ultrasound technique using electronic focusing. High-gain electronics recovers reflected ultrasound signals displayed on a computer screen. Automatic scanning obtains multiple, sequential two-dimensional images, which can be compiled into a three-dimensional data set for viewing in three planes.

Indications for use as stated in the FDA summary.

More from U-Systems, Inc.

6 FDA decisions under this applicant name. See the company

  • K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
  • K032640Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound SystemU-Systems, Inc. · 2003
  • K013902U-Systems Diagnostic Ultrasound System Usi-2000U-Systems, Inc. · 2002
  • K013848U-Systems Diagnostic Ultrasound System U-2000U-Systems, Inc. · 2002
  • K003479U-Systems Ultrasound System Usi-2000U-Systems, Inc. · 2001

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/K022517 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022517: Usi-2000 Ultrasound System with Automated Scanning Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022517

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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