510(k) Report

510(k) · Cleared

Cleared

Ausonics Opus 2 Realtime Ultrasound Scanner

K945957510(k) TraditionalCleared Apr 15, 1996496-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

Kleinfeld, Kaplan and Becker · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Apr 15, 1996 after a 496-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.

Decided
Apr 15, 1996
Review
496 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared2005: 2 descendants cleared2003: 1 descendant cleared2004: 1 descendant cleared2012: 2 descendants cleared2008: 1 descendant cleared2013: 1 descendant cleared2014: 2 descendants cleared1995200020052010201520202025
  1. This deviceK945957 Ausonics Opus 2 Realtime Ultrasound ScannerKleinfeld, Kaplan and Becker · 1996
  2. Descendant · cites it directly · 10 of its ownK981424 Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998
  3. Descendant · 2 generations on · 4 of its ownK032100 I-BEAMComputerized Medical Systems, Inc. · 2003
  4. Descendant · 2 generations on · 3 of its ownK042110 BeamcathBeampoint AB · 2005
  5. Descendant · 2 generations on · 3 of its ownK041937 RestituResonant Medical, Inc. · 2004
  6. Descendant · 3 generations on · 2 of its ownK111332 Clarity Obp SystemElekta, Ltd. · 2012

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1998: 12003: 12004: 12005: 22008: 12012: 22013: 12014: 2
1998high 2 (2005) · low 0 (1999)2026

Most influential descendants

Showing 5 of 11 · See all
  • K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998 · cites it directly10descendants
  • K032100I-BEAMComputerized Medical Systems, Inc. · 2003 · 2 generations on4descendants
  • K042110BeamcathBeampoint AB · 2005 · 2 generations on3descendants
  • K041937RestituResonant Medical, Inc. · 2004 · 2 generations on3descendants
  • K111332Clarity Obp SystemElekta, Ltd. · 2012 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945957Ausonics Opus 2 Realtime Ultrasound ScannerKleinfeld, Kaplan and Becker1996—
+1K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp.1998—
+2K032100I-BEAMComputerized Medical Systems, Inc.2003—
+2K042110BeamcathBeampoint AB2005—
+2K041937RestituResonant Medical, Inc.2004—
+3K111332Clarity Obp SystemElekta, Ltd.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200310
200410
200520
200810
201220
201310
201420
FIG. 1 — Lineage of K945957, 1996–2014Source: 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp.199810

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, K981424 (Nomos Corp., 1998) has gone furthest, with 10 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 Kleinfeld, Kaplan and Becker

2 FDA decisions under this applicant name. See the company

  • K950815ChampionKleinfeld, Kaplan and Becker · 1995

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/K945957 · printed Nov 5, 2026

Cite this page

510(k) Report. “K945957: Ausonics Opus 2 Realtime Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945957

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026