510(k) · Cleared

Cleared

Picture Archiving and Communication Systems

K925965510(k) TraditionalCleared Jun 14, 1993201-day reviewClass II21 CFR 892.1560

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

Advanced Light Imaging Technologies, Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jun 14, 1993 after a 201-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 45 later devices descend from it.

Decided: Jun 14, 1993
Review: 201 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 0

45 later devices descend from it, 3 citing it directly.

This deviceK925965 Picture Archiving and Communication SystemsAdvanced Light Imaging Technologies, Ltd. · 1993
Descendant · cites it directly · 27 of its ownK043146 Horizon Medical ImagingMckesson Medical Imaging Company · 2005 · Recalled
Descendant · cites it directly · 16 of its ownK023772 Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 2002 · Recalled
Descendant · 2 generations on · 13 of its ownK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
Descendant · 2 generations on · 10 of its ownK051649 Vericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems · 2005 · Recalled
Descendant · 2 generations on · 7 of its ownK152186 HealthMyne PACSHealthmyne, Inc. · 2015

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

1998high 7 (2005) · low 0 (1999)2026

Most influential descendants

Showing 5 of 45 · See all

K043146Horizon Medical ImagingMckesson Medical Imaging Company · 2005 · cites it directly27descendants
K023772Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 2002 · cites it directly16descendants
K041029KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · 2 generations on13descendants
K051649Vericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems · 2005 · 2 generations on10descendants
K152186HealthMyne PACSHealthmyne, Inc. · 2015 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K925965	Picture Archiving and Communication Systems	Advanced Light Imaging Technologies, Ltd.	1993	—
+1	K043146	Horizon Medical Imaging	Mckesson Medical Imaging Company	2005	11
+1	K023772	Kinetdx Picture Archiving and Communications System	Acuson Corp.	2002	5
+2	K041029	Kinetdx	Siemens Medi Cal Solutions, Inc.	2004	1
+2	K051649	Vericis Cardiovascular Image and Information System, Model 4.0	Camtronics Medical Systems	2005	17
+2	K152186	HealthMyne PACS	Healthmyne, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0
2003	1	0
2004	1	0
2005	7	0
2006	1	0
2007	2	0
2008	2	0
2010	2	0
2011	4	0
2012	3	0
2013	1	0
2014	2	0
2015	2	0
2016	1	0
2017	1	0
2018	2	0
2019	2	0
2020	1	0
2021	2	0
2022	2	0
2023	1	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K925965, 1993–2025Source: 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.

Planning a device in IYO? 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 IYO device

#1 K243937 Accuro 3Sscore 20.5 · 18 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (45)

See all 45

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

Number	Device	Applicant	Decided	Descendants
K043146	Horizon Medical Imaging	Mckesson Medical Imaging Company	2005	27
K023772	Kinetdx Picture Archiving and Communications System	Acuson Corp.	2002	16
K982563	Ultrapro Model 98	Ramsoft, Inc.	1998	7

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?

Of its descendants, K043146 (Mckesson Medical Imaging Company, 2005) has gone furthest, with 27 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

https://510kreport.com/device/K925965 · printed Nov 5, 2026

Cite this page

510(k) Report. “K925965: Picture Archiving and Communication Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925965

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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