510(k) · Cleared

Cleared

Picus Ultrasound Imaging Systems

K023512510(k) TraditionalCleared Jan 24, 200395-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

Pie Medical · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jan 24, 2003 as substantially equivalent to K002880 (Pie Medical, 2000) and 1 other predicate after a 95-day review. Its family tree reaches back 1 generation to 2000. 32 later devices descend from it.

Decided: Jan 24, 2003
Review: 95 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K000931 (2000). 2 ancestors in all. 32 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK000931 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 2000
This deviceK023512 Picus Ultrasound Imaging SystemsPie Medical · 2003
Descendant · cites it directly · 30 of its ownK043588 Mylab 15 / Mylab 20, Model 2700Pie Medical · 2005
Descendant · 2 generations on · 29 of its ownK053154 MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005
Descendant · 2 generations on · 28 of its ownK061755 MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006
Descendant · 2 generations on · 27 of its ownK070903 MYLAB40Esaote Europe B.V. · 2007
Descendant · 3 generations on · 26 of its ownK083882 MylabfiveEsaote Europe B.V. · 2009

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2004high 4 (2016) · low 0 (2008)2026

Most influential descendants

Showing 5 of 32 · See all

K043588Mylab 15 / Mylab 20, Model 2700Pie Medical · 2005 · cites it directly30descendants
K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005 · 2 generations on29descendants
K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006 · 2 generations on28descendants
K070903MYLAB40Esaote Europe B.V. · 2007 · 2 generations on27descendants
K083882MylabfiveEsaote Europe B.V. · 2009 · 3 generations on26descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000931	AU5 Ultrasound Imaging System	Biosound Esaote, Inc.	2000	—
0 (this device)	K023512	Picus Ultrasound Imaging Systems	Pie Medical	2003	—
+1	K043588	Mylab 15 / Mylab 20, Model 2700	Pie Medical	2005	—
+2	K053154	MYLAB15/20 3D/4D Ultrasound Imaging System	Pie Medical	2005	—
+2	K061755	MYLAB15/20 New Indications Ultrasound System	Esaote Europe B.V.	2006	—
+2	K070903	MYLAB40	Esaote Europe B.V.	2007	—
+3	K083882	Mylabfive	Esaote Europe B.V.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2006	1	0
2007	1	0
2009	1	0
2010	1	0
2011	1	0
2013	2	0
2014	3	0
2016	4	0
2017	3	0
2018	2	0
2019	4	0
2021	1	0
2023	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K023512, 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
*	K002880	300LC Ultrasound Imaging Systems, Model 300LC Summary page 3 …l organ, neonatal cephalic, transrectal and transvaginal. 510(k) Summary Picus 3D Pie Medical Comparison Chart for Substantial Equivalence General Picus K002880 Esaote AU5 3D K000931 \|Pie Medical Picus 3D characteristics This submission Transducer type Annular Array No Yes No Mechanical Se…	Pie Medical	2000	—
*	K000931	AU5 Ultrasound Imaging System Summary page 3 …alic, transrectal and transvaginal. 510(k) Summary Picus 3D Pie Medical Comparison Chart for Substantial Equivalence General Picus K002880 Esaote AU5 3D K000931 \|Pie Medical Picus 3D characteristics This submission Transducer type Annular Array No Yes No Mechanical Sector No Yes No Linear…	Biosound Esaote, Inc.	2000	—

Also cleared against K002880: 1 other device →

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K043588	Mylab 15 / Mylab 20, Model 2700	Pie Medical	2005	30
K041675	Picus, Parus, Falco and Aquila Ultrasound Systems	Pie Medical	2004	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?

None of the 2 ancestors has a recall.
Of its descendants, K043588 (Pie Medical, 2005) has gone furthest, with 30 descendants of its own.
1 other device also cites its predicate K002880.

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?

Pie Medical’s Picus 3D ultrasound system is intended to be used by a physician to perform general diagnostic ultrasound studies including cardiac, peripheral vascular, fetal, abdominal, small organ, neonatal cephalic, transrectal and transvaginal.

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/K023512 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023512: Picus Ultrasound Imaging Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023512

Report an extraction error

Are you the manufacturer?

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