510(k) · Cleared

Cleared

Supernova Diagnostic Ultrasound Scanning System

K022858510(k) TraditionalCleared Sep 6, 20029-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

Novasonics, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Sep 6, 2002 as substantially equivalent to K002003 (Atl Ultrasound, Inc., 2000) and 1 other predicate after a 9-day review. Its family tree reaches back 1 generation to 2000. 134 later devices descend from it.

Decided: Sep 6, 2002
Review: 9 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K002003 (2000). 2 ancestors in all. 134 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK002003 Hdi 5000 Ultrasound System with Extended Field of View ImagingAtl Ultrasound, Inc. · 2000
This deviceK022858 Supernova Diagnostic Ultrasound Scanning SystemNovasonics, Inc. · 2002
Descendant · cites it directly · 133 of its ownK082326 Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc. · 2008
Descendant · cites it directly · 132 of its ownK101091 Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc. · 2010
Descendant · 2 generations on · 98 of its ownK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
Descendant · 3 generations on · 96 of its ownK123622 AcusonSiemens Medical Solutions USA, Inc. · 2012 · Recalled
Descendant · 3 generations on · 74 of its ownK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled

Showing 5 of 134 descendants. See all descendants

Descendants cleared per year

2008high 13 (2022) · low 0 (2009)2026

Most influential descendants

Showing 5 of 134 · See all

K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc. · 2008 · cites it directly133descendants
K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc. · 2010 · cites it directly132descendants
K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on98descendants
K123622AcusonSiemens Medical Solutions USA, Inc. · 2012 · 3 generations on96descendants
K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 3 generations on74descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002003	Hdi 5000 Ultrasound System with Extended Field of View Imaging	Atl Ultrasound, Inc.	2000	—
0 (this device)	K022858	Supernova Diagnostic Ultrasound Scanning System	Novasonics, Inc.	2002	—
+1	K082326	Zonare Ultra Ultrasound System	Zonare Medical Systems, Inc.	2008	—
+1	K101091	Z.One Ultra Ultrasound System	Zonare Medical Systems, Inc.	2010	—
+2	K121699	Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound…	Siemens Medical Solutions USA, Inc.	2012	—
+3	K123622	Acuson	Siemens Medical Solutions USA, Inc.	2012	13
+3	K123001	Acuson X700 Diagnstic Ultrasound System	Siemens Medical Solutions USA, Inc.	2012	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0
2011	1	0
2012	5	0
2013	4	0
2014	10	0
2015	5	0
2016	8	0
2017	9	0
2018	9	0
2019	7	0
2020	12	0
2021	10	0
2022	13	0
2023	10	0
2024	11	0
2025	13	0
2026	5	0

FIG. 1 — Lineage of K022858, 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? (2)

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
*	K002003	Hdi 5000 Ultrasound System with Extended Field of View Imaging	Atl Ultrasound, Inc.	2000	—
*	K011188	GE Logiq 9, Model 2188900-X	GE Medical Systems	2001	—

Also cleared against K002003: 7 other devices →

What descends from it? (134)

See all 134

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

Number	Device	Applicant	Decided	Descendants
K082326	Zonare Ultra Ultrasound System	Zonare Medical Systems, Inc.	2008	133
K101091	Z.One Ultra Ultrasound System	Zonare Medical Systems, Inc.	2010	132

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?

None of the 2 ancestors has a recall.
Of its descendants, K082326 (Zonare Medical Systems, Inc., 2008) has gone furthest, with 133 descendants of its own.
7 other devices also cite its predicate K002003.

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?

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Trans-esoph. (non-cardiac); Cardiac Adult; Cardiac Pediatric; Trans-esoph (Cardiac), Peripheral Vessel.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022858 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022858: Supernova Diagnostic Ultrasound Scanning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022858

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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