510(k) · Cleared

Cleared

Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BM

K101236510(k) TraditionalCleared Feb 8, 2011281-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

GE Healthcare · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Feb 8, 2011 as substantially equivalent to K061682 (General Electric Co., 2006) after a 281-day review. Its family tree reaches back 4 generations to 2000. 445 later devices descend from it.

Decided: Feb 8, 2011
Review: 281 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K003525 (2000). 445 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 4 generations backK003525 Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
3 generations backK032620 GE Voluson 730 Pro/Expert BT03 Ultrasound SystemGeneral Electric Co. · 2003
2 generations backK041688 GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co. · 2004 · Recalled
1 generation backK061682 GE Voluson E8 Ultrasound SystemGeneral Electric Co. · 2006 · Recalled
This deviceK101236 Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model…GE Healthcare · 2011
Descendant · cites it directly · 404 of its ownK112213 Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound SystemGE Healthcare · 2011 · Recalled
Descendant · 2 generations on · 402 of its ownK113758 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
Descendant · 3 generations on · 365 of its ownK122327 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
Descendant · 4 generations on · 323 of its ownK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
Descendant · 2 generations on · 295 of its ownK120741 Voluson S6, Voluson S8GE Healthcare · 2012

Showing 5 of 445 descendants. See all descendants

Descendants cleared per year

2011high 41 (2020) · low 2 (2011)2026

Most influential descendants

Showing 5 of 445 · See all

K112213Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound SystemGE Healthcare · 2011 · cites it directly404descendants
K113758Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · 2 generations on402descendants
K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · 3 generations on365descendants
K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · 4 generations on323descendants
K120741Voluson S6, Voluson S8GE Healthcare · 2012 · 2 generations on295descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K003525	Voluson 730 Diagnostic Ultrasound System	Medison America, Inc.	2000	—
−3	K032620	GE Voluson 730 Pro/Expert BT03 Ultrasound System	General Electric Co.	2003	—
−2	K041688	GE Voluson 730 Pro/Expert Untrasound BT04	General Electric Co.	2004	1
−1	K061682	GE Voluson E8 Ultrasound System	General Electric Co.	2006	3
0 (this device)	K101236	Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/…	GE Healthcare	2011	—
+1	K112213	Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System	GE Healthcare	2011	1
+2	K113758	Voluson E6/E8/E8EXPERT/E10	GE Healthcare	2012	—
+3	K122327	Voluson E6/E8/E8EXPERT/E10	GE Healthcare	2012	—
+4	K123564	Logiq E9 Diagnostic Ultrasound System	GE Healthcare	2012	1
+2	K120741	Voluson S6, Voluson S8	GE Healthcare	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	14	0
2013	11	0
2014	17	0
2015	25	0
2016	28	0
2017	36	0
2018	40	0
2019	28	0
2020	41	0
2021	31	0
2022	34	0
2023	29	0
2024	39	0
2025	41	0
2026	29	0

FIG. 1 — Lineage of K101236, 2000–2026Source: 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
*	K061682	GE Voluson E8 Ultrasound System Summary page 1 …onic Pulsed Echo Imaging System, 2ICFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): K061682 Voluson £8 Diagnostic Ultrasound System Device Description: The Voluson E6IE8IE8Expert BTIO system is a full-featured…	General Electric Co.	2006	3
†	K092271	GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4	GE Healthcare	2009	1

Also cleared against K061682: 6 other devices →

What descends from it? (445)

See all 445

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

Number	Device	Applicant	Decided	Descendants
K112213	Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System	GE Healthcare	2011	404
K113647	DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2011	116
K132341	DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2013	96
K141010	M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2014	83
K140030	DC-N3/DC-N3S Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2014	5
K120801	Chison Diagnostic Ultrasound System	Chison Medical Imaging Co., Ltd.	2012	1
K140364	Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and Convex…	Chison Medical Imaging Co., Ltd.	2014	0
K113359	Chison Diagnostic Ultrasound System,Convex Probe,Linear Probe,Transvaginal Micro-Convex…	Chison Medical Imaging Co., Ltd.	2012	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?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
2 of the 4 ancestors have a recall of any class.
Of its descendants, K112213 (GE Healthcare, 2011) has gone furthest, with 404 descendants of its own.
6 other devices also cite its predicate K061682.

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. 2011, this device’s year, is highlighted.

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?

The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN. pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and Pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and lntraoperative (abdominal, PV and neurological).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101236 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101236: Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101236

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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