510(k) · Cleared

Cleared

Hdi 5000 Ultrasound System with Extended Field of View Imaging

K002003510(k) TraditionalCleared Jul 13, 200013-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

Atl Ultrasound, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jul 13, 2000 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 824 devices in its family, counting itself, have a Class I recall. 823 later devices descend from it.

Decided: Jul 13, 2000
Review: 13 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 0

823 later devices descend from it, 8 citing it directly. 2 of the 824 devices in this family, counting this one, have a Class I recall.

This deviceK002003 Hdi 5000 Ultrasound System with Extended Field of View ImagingAtl Ultrasound, Inc. · 2000
Descendant · cites it directly · 677 of its ownK034003 Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
Descendant · 2 generations on · 676 of its ownK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
Descendant · cites it directly · 595 of its ownK020630 Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation · 2002
Descendant · cites it directly · 590 of its ownK042326 Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation · 2004
Descendant · cites it directly · 586 of its ownK061827 Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2006

Showing 5 of 823 descendants. See all descendants

Descendants cleared per year

2002high 68 (2017) · low 1 (2003)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System7 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System7 generations on · 2025

Most influential descendants

Showing 5 of 823 · See all

K034003Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · cites it directly677descendants
K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · 2 generations on676descendants
K020630Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation · 2002 · cites it directly595descendants
K042326Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation · 2004 · cites it directly590descendants
K061827Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2006 · cites it directly586descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002003	Hdi 5000 Ultrasound System with Extended Field of View Imaging	Atl Ultrasound, Inc.	2000	—
+1	K034003	Hdi 5000 Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2004	4
+2	K053069	Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)	Sonosite,Inc.	2005	3
+1	K020630	Ultrasonix Ergosonix 500 Ultrasound Scanner	Ultrasonix Medical Corporation	2002	—
+1	K042326	Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner	Ultrasonix Medical Corporation	2004	—
+1	K061827	Sonix Ultrasound Scanner	Ultrasonix Medical Corporation	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2003	1	0
2004	2	0
2005	1	0
2006	1	0
2007	3	0
2008	6	0
2009	8	0
2010	10	0
2011	16	0
2012	29	0
2013	34	0
2014	44	0
2015	51	0
2016	61	0
2017	68	0
2018	60	0
2019	44	0
2020	62	0
2021	50	0
2022	51	0
2023	49	0
2024	55	0
2025	68	2
2026	46	0

FIG. 1 — Lineage of K002003, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 devices in this family have a Class I recall. 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (823)

See all 823

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

Number	Device	Applicant	Decided	Descendants
K034003	Hdi 5000 Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2004	677
K020630	Ultrasonix Ergosonix 500 Ultrasound Scanner	Ultrasonix Medical Corporation	2002	595
K042326	Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner	Ultrasonix Medical Corporation	2004	590
K061827	Sonix Ultrasound Scanner	Ultrasonix Medical Corporation	2006	586
K030455	Boris Platform Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2003	535
K022858	Supernova Diagnostic Ultrasound Scanning System	Novasonics, Inc.	2002	134
K070195	Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B	Broadsound Corporation	2007	0
K014182	Tetrad Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-Atp Transducers	Tetrad Corp.	2002	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K034003 (Philips Ultrasound, Inc., 2004) has gone furthest, with 677 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

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)	—

https://510kreport.com/device/K002003 · printed Nov 3, 2026

Cite this page

510(k) Report. “K002003: Hdi 5000 Ultrasound System with Extended Field of View Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K002003

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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