510(k) · Cleared

Recalled · Class II · 2025

Boris Platform Diagnostic Ultrasound System

K030455510(k) TraditionalCleared Mar 13, 200330-day reviewClass II21 CFR 892.1550Recalls 31

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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

Cleared on Mar 13, 2003 as substantially equivalent to K961459 (Advanced Technology Laboratories, Inc., 1997) and 2 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1997. 2 of the 539 devices in its family, counting itself, have a Class I recall. 535 later devices descend from it. It has been recalled 31 times.

Decided: Mar 13, 2003
Review: 30 days
Class: Class II
Product code: IYN
Recalls: 31
Predicates: 3

Its longest line of descent runs back 1 generation to K961459 (1997). 3 ancestors in all. 535 later devices descend from it, 6 citing it directly. 2 of the 539 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK961459 Level 10 HdiAdvanced Technology Laboratories, Inc. · 1997
This deviceK030455 Boris Platform Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2003
Descendant · cites it directly · 528 of its ownK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
Descendant · 2 generations on · 527 of its ownK102041 AixplorerSupersonic Imagine · 2010
Descendant · 2 generations on · 525 of its ownK112255 AixplorerSupersonic Imagine · 2012
Descendant · 3 generations on · 405 of its ownK121329 AixplorerSupersonic Imagine · 2012
Descendant · 3 generations on · 312 of its ownK132274 AixplorerSupersonic Imagine · 2013

Showing 5 of 535 descendants. See all descendants

Descendants cleared per year

2009high 54 (2025) · low 1 (2010)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System6 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System6 generations on · 2025

Most influential descendants

Showing 5 of 535 · See all

K091970Aixplorer Ultrasound SystemSupersonic Imagine · 2009 · cites it directly528descendants
K102041AixplorerSupersonic Imagine · 2010 · 2 generations on527descendants
K112255AixplorerSupersonic Imagine · 2012 · 2 generations on525descendants
K121329AixplorerSupersonic Imagine · 2012 · 3 generations on405descendants
K132274AixplorerSupersonic Imagine · 2013 · 3 generations on312descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961459	Level 10 Hdi	Advanced Technology Laboratories, Inc.	1997	—
0 (this device)	K030455	Boris Platform Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2003	—
+1	K091970	Aixplorer Ultrasound System	Supersonic Imagine	2009	—
+2	K102041	Aixplorer	Supersonic Imagine	2010	—
+2	K112255	Aixplorer	Supersonic Imagine	2012	—
+3	K121329	Aixplorer	Supersonic Imagine	2012	—
+3	K132274	Aixplorer	Supersonic Imagine	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	3	0
2010	1	0
2011	1	0
2012	3	0
2013	10	0
2014	16	0
2015	30	0
2016	36	0
2017	49	0
2018	41	0
2019	32	0
2020	47	0
2021	45	0
2022	44	0
2023	38	0
2024	45	0
2025	54	2
2026	40	0

FIG. 1 — Lineage of K030455, 1997–2026Source: 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.

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

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What was it cleared against? (3)

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
*	K961459	Level 10 Hdi Summary page 1 …eves that the Boris Platform system and transducers are substantially equivalent to the currently marketed Philips HDIB 5000 ultrasound system and transducers cleared in K961459, K991671, and K002003. 3) Device Description The Boris system is a general purpose, mobile, software controlled, diagnostic ult…	Advanced Technology Laboratories, Inc.	1997	—
*	K991671	Hdi 5000 Diagnostic Ultrasound System Summary page 1 …the Boris Platform system and transducers are substantially equivalent to the currently marketed Philips HDIB 5000 ultrasound system and transducers cleared in K961459, K991671, and K002003. 3) Device Description The Boris system is a general purpose, mobile, software controlled, diagnostic ultrasound s…	Advanced Technology Laboratories, Inc.	1999	—
*	K002003	Hdi 5000 Ultrasound System with Extended Field of View Imaging Summary page 1 …atform system and transducers are substantially equivalent to the currently marketed Philips HDIB 5000 ultrasound system and transducers cleared in K961459, K991671, and K002003. 3) Device Description The Boris system is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its fu…	Atl Ultrasound, Inc.	2000	—

Also cleared against K961459: 15 other devices →

What descends from it? (535)

See all 535

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

Number	Device	Applicant	Decided	Descendants
K091970	Aixplorer Ultrasound System	Supersonic Imagine	2009	528
K132304	Epiq Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2013	211
K091804	CX50 Version 2.0 Diagnostic Ultrasound System and Transducers	Philips Ultrasound, Inc.	2009	57
K123754	CX50 3.0 Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2012	53
K173090	Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4	Toshibamedical Systems Corporation	2018	21
K083877	Flying Diagnostic Ultrasound System	Neusoft Medical Systems Co., Ltd.	2009	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 5, 2025	Class III	Z-1625-2026	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Class III	Z-1621-2026	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Class III	Z-1619-2026	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025	Class III	Z-1620-2026	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2390-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2371-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2368-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2377-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2367-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2379-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2378-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2381-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2402-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2365-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2376-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2382-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2359-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2358-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2357-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2366-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2391-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2353-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2363-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
May 28, 2025	Class II	Z-2050-2025	Process control	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Class II	Z-2056-2025	Process control	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Class II	Z-2051-2025	Process control	Ultrasound transducer devices were refurbished beyond their useful life.
May 28, 2025	Class II	Z-2057-2025	Process control	Ultrasound transducer devices were refurbished beyond their useful life.
Aug 30, 2019	Class II	Z-1844-2020	Process control	The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of…
Aug 30, 2019	Class II	Z-1842-2020	Process control	The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of…
Mar 27, 2011	Not classified	Z-2062-2011	Other	Users of the Philips model S8-3t Micro TEE Transducer have reported that significant image quality degradation may occur after a number of use/cleaning cycles. If users do not inspect the transducer for such damage prior to each use…
Nov 2, 2006	Not classified	Z-0422-2007	Other	Acoustic output intensity may exceed maximum specified limits and the patient contact temperature may exceed 43 degree C (when the system is used with the S12-4 transducer in CW-mode)

The 5 latest of 31 recalls; the web page lists all.

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 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K091970 (Supersonic Imagine, 2009) has gone furthest, with 528 descendants of its own.
15 other devices also cite its predicate K961459.

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 as stated in the FDA summary.

https://510kreport.com/device/K030455 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030455: Boris Platform Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030455

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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