510(k) Report

510(k) · Cleared

Cleared

Dicomit

K951925510(k) TraditionalCleared Jul 12, 199578-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

Dicomit Imaging Systems Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jul 12, 1995 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 215 later devices descend from it.

Decided
Jul 12, 1995
Review
78 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

215 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 3 descendants cleared2002: 1 descendant cleared2001: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2005: 2 descendants cleared2007: 3 descendants cleared2008: 5 descendants cleared2015: 5 descendants cleared2009: 5 descendants cleared2017: 12 descendants cleared2016: 7 descendants cleared2013: 4 descendants cleared2011: 4 descendants cleared2012: 8 descendants cleared2018: 18 descendants cleared2010: 1 descendant cleared2014: 10 descendants cleared2019: 8 descendants cleared2023: 18 descendants cleared2025: 26 descendants cleared2020: 20 descendants cleared2021: 9 descendants cleared2026: 13 descendants cleared2022: 16 descendants cleared2024: 13 descendants cleared1995200020052010201520202025
  1. This deviceK951925 DicomitDicomit Imaging Systems Corp. · 1995
  2. Descendant · cites it directly · 213 of its ownK990248 Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp. · 1999
  3. Descendant · 2 generations on · 212 of its ownK992886 Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C · 1999
  4. Descendant · 3 generations on · 211 of its ownK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
  5. Descendant · 3 generations on · 210 of its ownK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
  6. Descendant · 4 generations on · 209 of its ownK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003

Showing 5 of 215 descendants. See all descendants

Descendants cleared per year

1999: 32001: 12002: 12003: 12004: 12005: 22006: 12007: 32008: 52009: 52010: 12011: 42012: 82013: 42014: 102015: 52016: 72017: 122018: 182019: 82020: 202021: 92022: 162023: 182024: 132025: 262026: 13
1999high 26 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 215 · See all
  • K990248Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp. · 1999 · cites it directly213descendants
  • K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C · 1999 · 2 generations on212descendants
  • K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001 · 3 generations on211descendants
  • K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · 3 generations on210descendants
  • K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003 · 4 generations on209descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951925DicomitDicomit Imaging Systems Corp.1995—
+1K990248Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp.1999—
+2K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C1999—
+3K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C2001—
+3K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C20021
+4K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199930
200110
200210
200310
200410
200520
200610
200730
200850
200950
201010
201140
201280
201340
2014100
201550
201670
2017120
2018180
201980
2020200
202190
2022160
2023180
2024130
2025260
2026130
FIG. 1 — Lineage of K951925, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYO? 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? (215)

See all 215

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

NumberDeviceApplicantDecidedDescendants
K990248Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp.1999213
K990256CRX World ShuntPhoenix Biomedical Corp.19990

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, K990248 (Dicomit Imaging Systems Corp., 1999) has gone furthest, with 213 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 Dicomit Imaging Systems Corp.

2 FDA decisions under this applicant name. See the company

  • K990248Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp. · 1999

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https://510kreport.com/device/K951925 · printed Nov 5, 2026

Cite this page

510(k) Report. “K951925: Dicomit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951925

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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