510(k) · Cleared

Cleared

Philips Easyvision Workstation Release 6

K023137510(k) TraditionalCleared Dec 19, 200290-day reviewClass II21 CFR 892.2050

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

Philips Medical Systems North America Co. · LLZ System, Image Processing, Radiological

Cleared on Dec 19, 2002 as substantially equivalent to K920950 (Philips Medical Systems, Inc., 1992) after a 90-day review. Its family tree reaches back 1 generation to 1992. 12 later devices descend from it.

Decided: Dec 19, 2002
Review: 90 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K920950 (1992). 12 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK920950 Philips EasyvisionPhilips Medical Systems, Inc. · 1992 · Recalled
This deviceK023137 Philips Easyvision Workstation Release 6Philips Medical Systems North America Co. · 2002
Descendant · cites it directly · 6 of its ownK032096 Philips Viewforum 2003Philips Medical Systems · 2003 · Recalled
Descendant · cites it directly · 4 of its ownK111833 VirtueDiagnosoft, Inc. · 2011
Descendant · 2 generations on · 2 of its ownK163076 Segment CMRMedviso AB · 2017
Descendant · 2 generations on · 2 of its ownK081262 DC NeuroInvivo Corporation · 2008
Descendant · 3 generations on · 1 of its ownK113701 Visia NeuroMeVis Medical Solutions AG · 2012

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2003high 2 (2011) · low 0 (2004)2026

Most influential descendants

Showing 5 of 12 · See all

K032096Philips Viewforum 2003Philips Medical Systems · 2003 · cites it directly6descendants
K111833VirtueDiagnosoft, Inc. · 2011 · cites it directly4descendants
K163076Segment CMRMedviso AB · 2017 · 2 generations on2descendants
K081262DC NeuroInvivo Corporation · 2008 · 2 generations on2descendants
K113701Visia NeuroMeVis Medical Solutions AG · 2012 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K920950	Philips Easyvision	Philips Medical Systems, Inc.	1992	1
0 (this device)	K023137	Philips Easyvision Workstation Release 6	Philips Medical Systems North America Co.	2002	—
+1	K032096	Philips Viewforum 2003	Philips Medical Systems	2003	2
+1	K111833	Virtue	Diagnosoft, Inc.	2011	—
+2	K163076	Segment CMR	Medviso AB	2017	—
+2	K081262	DC Neuro	Invivo Corporation	2008	—
+3	K113701	Visia Neuro	MeVis Medical Solutions AG	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0
2008	1	0
2011	2	0
2012	1	0
2013	1	0
2014	2	0
2017	1	0
2022	1	0
2024	1	0

FIG. 1 — Lineage of K023137, 1992–2024Source: 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 LLZ? 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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? (1)

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
*	K920950	Philips Easyvision Summary page 2 …nts are taken. Substantial equivalence: The Philips Easyvision Workstation Release 6 is substantially equivalent to the Easyvision Workstation systems (K920950). . (@a DEPARTMENT OF HEALTH 8a HUMAN SERVICES Public Health Service…	Philips Medical Systems, Inc.	1992	1

Also cleared against K920950: 4 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K032096	Philips Viewforum 2003	Philips Medical Systems	2003	6
K111833	Virtue	Diagnosoft, Inc.	2011	4

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?

Its one ancestor has a recall.
Of its descendants, K032096 (Philips Medical Systems, 2003) has gone furthest, with 6 descendants of its own.
4 other devices also cite its predicate K920950.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

The Easyvision Workstation Release 6 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of “off-the-shelf” standard computer components. The Easyvision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023137 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023137: Philips Easyvision Workstation Release 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023137

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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