510(k) · Cleared

Cleared

Combison 530D with Power Doppler Mode

K974813510(k) TraditionalCleared Sep 29, 1998280-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

Medison America, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Sep 29, 1998 as substantially equivalent to K933743 (Toshiba America Medical Systems, In.C, 1994) after a 280-day review. Its family tree reaches back 1 generation to 1994. 211 later devices descend from it.

Decided: Sep 29, 1998
Review: 280 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K933743 (1994). 211 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK933743 SSA-380AToshiba America Medical Systems, In.C · 1994
This deviceK974813 Combison 530D with Power Doppler ModeMedison America, Inc. · 1998
Descendant · cites it directly · 208 of its ownK992155 Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion…Medison America, Inc. · 1999
Descendant · 2 generations on · 207 of its ownK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
Descendant · 3 generations on · 204 of its ownK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
Descendant · 3 generations on · 184 of its ownK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
Descendant · 4 generations on · 182 of its ownK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004

Showing 5 of 211 descendants. See all descendants

Descendants cleared per year

1999high 17 (2018) · low 0 (2002)2026

Most influential descendants

Showing 5 of 211 · See all

K992155Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion Abdominal Transducer, Model…Medison America, Inc. · 1999 · cites it directly208descendants
K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · 2 generations on207descendants
K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001 · 3 generations on204descendants
K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · 3 generations on184descendants
K043455SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004 · 4 generations on182descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933743	SSA-380A	Toshiba America Medical Systems, In.C	1994	—
0 (this device)	K974813	Combison 530D with Power Doppler Mode	Medison America, Inc.	1998	—
+1	K992155	Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion Abdominal…	Medison America, Inc.	1999	—
+2	K002185	Sonoace SA 9900 Diagnostic Ultrasound System	Medison America, Inc.	2000	1
+3	K013627	Sonoace SA-8000 Diagnostic Ultrasound System	Medison America, Inc.	2001	—
+3	K031552	Mycolor 202 Diagnostic Ultrasound System and Transducers	Medison America, Inc.	2003	5
+4	K043455	SA8000 SE Diagnostic Ultrasound System	Medison Co., Ltd.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	3	0
2000	1	0
2001	2	0
2003	2	0
2004	2	0
2005	3	0
2006	6	0
2007	3	0
2008	4	0
2009	5	0
2010	7	0
2011	9	0
2012	5	0
2013	7	0
2014	9	0
2015	5	0
2016	11	0
2017	15	0
2018	17	0
2019	17	0
2020	11	0
2021	13	0
2022	14	0
2023	10	0
2024	9	0
2025	13	0
2026	8	0

FIG. 1 — Lineage of K974813, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K933743	SSA-380A Summary page 1 …eiker Medison America, Inc 6616 Owens Drive Pleasanton, CA 94588 Vice President, Regulatory Affairs and Quality Assurance (510) 463-1830 (510) 463-2646 Toshiba SSA380 K933743 See Attached Display of slow blood flows by displaying the Doppler backscatter amplitude of the fluid. The Power Doppler (a k.…	Toshiba America Medical Systems, In.C	1994	—

Also cleared against K933743: 6 other devices →

What descends from it? (211)

See all 211

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

Number	Device	Applicant	Decided	Descendants
K992155	Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion Abdominal Transducer, Model…	Medison America, Inc.	1999	208
K992761	Sonoace 5500 Diagnostic Ultrasound System	Medison America, Inc.	1999	33
K984639	The S-Vna 5-8(B) Diagnostic Ultrasound Transducer	Medison America, Inc.	1999	0

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?

Its one ancestor has no recall.
Of its descendants, K992155 (Medison America, Inc., 1999) has gone furthest, with 208 descendants of its own.
6 other devices also cite its predicate K933743.

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

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYN

10in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	13	26	16	3
2008	25	18	12	2
2009	18	29	8	9
2010	29	67	10	17
2011	39	46	8	18
2012	43	37	3	20
2013	51	60	8	18
2014	56	39	2	48
2015	54	55	3	116
2016	60	56	2	145
2017	64	83	0	146
2018	59	85	7	85
2019	47	79	0	59
2020	57	72	4	67
2021	46	105	8	213
2022	53	105	10	186
2023	44	115	4	229
2024	50	119	1	266
2025	57	124	10	610
2026	44	107	2 (1)	—

What is it indicated for?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974813 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974813: Combison 530D with Power Doppler Mode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974813

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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