510(k) Report

510(k) · Cleared

Cleared

NEMIO

K010631510(k) TraditionalCleared Mar 15, 200113-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

Toshiba America Medical Systems, In.C · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Mar 15, 2001 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 203 later devices descend from it.

Decided
Mar 15, 2001
Review
13 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
0

203 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2007: 2 descendants cleared2004: 1 descendant cleared2005: 2 descendants cleared2015: 19 descendants cleared2016: 11 descendants cleared2009: 3 descendants cleared2010: 7 descendants cleared2018: 13 descendants cleared2013: 9 descendants cleared2008: 4 descendants cleared2011: 9 descendants cleared2012: 7 descendants cleared2017: 25 descendants cleared2020: 13 descendants cleared2014: 2 descendants cleared2019: 11 descendants cleared2022: 10 descendants cleared2025: 15 descendants cleared2024: 13 descendants cleared2023: 8 descendants cleared2021: 10 descendants cleared2026: 6 descendants cleared200020052010201520202025
  1. This deviceK010631 NEMIOToshiba America Medical Systems, In.C · 2001
  2. Descendant · cites it directly · 196 of its ownK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
  3. Descendant · cites it directly · 195 of its ownK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
  4. Descendant · 2 generations on · 194 of its ownK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
  5. Descendant · 3 generations on · 193 of its ownK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
  6. Descendant · cites it directly · 189 of its ownK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006

Showing 5 of 203 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 32007: 22008: 42009: 32010: 72011: 92012: 72013: 92014: 22015: 192016: 112017: 252018: 132019: 112020: 132021: 102022: 102023: 82024: 132025: 152026: 6
2004high 25 (2017) · low 1 (2004)2026

Most influential descendants

Showing 5 of 203 · See all
  • K043078Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · cites it directly196descendants
  • K051500Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005 · cites it directly195descendants
  • K053346Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 2 generations on194descendants
  • K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 3 generations on193descendants
  • K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · cites it directly189descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010631NEMIOToshiba America Medical Systems, In.C2001—
+1K043078Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C20041
+1K051500Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C2005—
+2K053346Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005—
+3K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006—
+1K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200630
200720
200840
200930
201070
201190
201270
201390
201420
2015190
2016110
2017250
2018130
2019110
2020130
2021100
2022100
202380
2024130
2025150
202660
FIG. 1 — Lineage of K010631, 2001–2026Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (203)

See all 203

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

NumberDeviceApplicantDecidedDescendants
K043078Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C2004196
K051500Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C2005195
K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189
K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188
K070526DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007117
K061605Nemio XG, Saa-580AToshiba America Medical Systems, In.C20065

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, K043078 (Toshiba America Medical Systems, In.C, 2004) has gone furthest, with 196 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 Toshiba America Medical Systems, In.C

146 FDA decisions under this applicant name. See the company

  • K141472Vantage ElanToshiba America Medical Systems, In.C · 2014
  • K133553KalareToshiba America Medical Systems, In.C · 20143 recalls
  • K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C · 2014
  • K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
  • K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C · 2013

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/K010631 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010631: NEMIO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010631

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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