510(k) Report

510(k) · Cleared

Cleared

Capasee

K933747510(k) TraditionalCleared May 13, 1994283-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

Toshiba America Medical Systems, In.C · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on May 13, 1994 after a 283-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 206 later devices descend from it.

Decided
May 13, 1994
Review
283 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2005: 3 descendants cleared2007: 2 descendants cleared2006: 3 descendants cleared2009: 4 descendants cleared2008: 5 descendants cleared2010: 8 descendants cleared2011: 10 descendants cleared2012: 8 descendants cleared2017: 26 descendants cleared2013: 9 descendants cleared2020: 13 descendants cleared2018: 12 descendants cleared2015: 17 descendants cleared2024: 14 descendants cleared2014: 2 descendants cleared2016: 10 descendants cleared2019: 11 descendants cleared2023: 8 descendants cleared2025: 15 descendants cleared2021: 10 descendants cleared2026: 6 descendants cleared2022: 9 descendants cleared1990200020102020
  1. This deviceK933747 CapaseeToshiba America Medical Systems, In.C · 1994
  2. Descendant · cites it directly · 205 of its ownK990490 Ssa-320A Just Vision 200/ Ssa-325A Just VisionToshiba America Medical Systems, In.C · 1999
  3. Descendant · 2 generations on · 195 of its ownK043563 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
  4. Descendant · 3 generations on · 194 of its ownK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
  5. Descendant · 4 generations on · 193 of its ownK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
  6. Descendant · 2 generations on · 192 of its ownK052113 DP-6600 Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005

Showing 5 of 206 descendants. See all descendants

Descendants cleared per year

1999: 12005: 32006: 32007: 22008: 52009: 42010: 82011: 102012: 82013: 92014: 22015: 172016: 102017: 262018: 122019: 112020: 132021: 102022: 92023: 82024: 142025: 152026: 6
1999high 26 (2017) · low 0 (2000)2026

Most influential descendants

Showing 5 of 206 · See all
  • K990490Ssa-320A Just Vision 200/ Ssa-325A Just VisionToshiba America Medical Systems, In.C · 1999 · cites it directly205descendants
  • K043563DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 2 generations on195descendants
  • K053346Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 3 generations on194descendants
  • K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 4 generations on193descendants
  • K052113DP-6600 Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 2 generations on192descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933747CapaseeToshiba America Medical Systems, In.C1994—
+1K990490Ssa-320A Just Vision 200/ Ssa-325A Just VisionToshiba America Medical Systems, In.C1999—
+2K043563DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2005—
+3K053346Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005—
+4K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006—
+2K052113DP-6600 Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200530
200630
200720
200850
200940
201080
2011100
201280
201390
201420
2015170
2016100
2017260
2018120
2019110
2020130
2021100
202290
202380
2024140
2025150
202660
FIG. 1 — Lineage of K933747, 1994–2026Source: 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
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? (206)

See all 206

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

NumberDeviceApplicantDecidedDescendants
K990490Ssa-320A Just Vision 200/ Ssa-325A Just VisionToshiba America Medical Systems, In.C1999205

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, K990490 (Toshiba America Medical Systems, In.C, 1999) has gone furthest, with 205 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—

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https://510kreport.com/device/K933747 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933747: Capasee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933747

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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