510(k) · Cleared

Recalled · 2008

Philips Easyvision

K920950510(k) TraditionalCleared Apr 27, 199261-day reviewClass II21 CFR 892.2050Recalls 1

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

Philips Medical Systems, Inc. · LLZ System, Image Processing, Radiological

Cleared on Apr 27, 1992 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 35 later devices descend from it. It has been recalled once.

Decided: Apr 27, 1992
Review: 61 days
Class: Class II
Product code: LLZ
Recalls: 1
Predicates: 0

35 later devices descend from it, 5 citing it directly.

This deviceK920950 Philips EasyvisionPhilips Medical Systems, Inc. · 1992
Descendant · cites it directly · 18 of its ownK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
Descendant · cites it directly · 17 of its ownK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
Descendant · 2 generations on · 16 of its ownK014240 ProntoHitachi Medical Systems America, Inc. · 2002
Descendant · 3 generations on · 15 of its ownK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
Descendant · 4 generations on · 12 of its ownK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

1996high 3 (2011) · low 0 (2000)2026

Most influential descendants

Showing 5 of 35 · See all

K982631Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998 · cites it directly18descendants
K991278Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999 · cites it directly17descendants
K014240ProntoHitachi Medical Systems America, Inc. · 2002 · 2 generations on16descendants
K040902Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · 3 generations on15descendants
K071806Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · 4 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K920950	Philips Easyvision	Philips Medical Systems, Inc.	1992	—
+1	K982631	Philips Tomoscan CS	Philips Medical Systems, Inc.	1998	—
+1	K991278	Philips Tomoscan AV-NT	Philips Medical Systems North America, Inc.	1999	—
+2	K014240	Pronto	Hitachi Medical Systems America, Inc.	2002	—
+3	K040902	Hitachi Presto	Hitachi Medical Systems America, Inc.	2004	4
+4	K071806	Eclos Computed Tomography X-Ray System	Hitachi Medical Systems America, Inc.	2007	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	1	0
1999	2	0
2002	2	0
2003	1	0
2004	2	0
2006	2	0
2007	1	0
2008	1	0
2009	1	0
2011	3	0
2012	2	0
2013	2	0
2014	3	0
2016	1	0
2017	2	0
2018	1	0
2022	2	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K920950, 1992–2026Source: 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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (35)

See all 35

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

Number	Device	Applicant	Decided	Descendants
K982631	Philips Tomoscan CS	Philips Medical Systems, Inc.	1998	18
K991278	Philips Tomoscan AV-NT	Philips Medical Systems North America, Inc.	1999	17
K023137	Philips Easyvision Workstation Release 6	Philips Medical Systems North America Co.	2002	12
K032096	Philips Viewforum 2003	Philips Medical Systems	2003	6
K961983	TRS 2000 Teleradiology System	Sectra-Imtec AB	1996	2

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 10, 2008	Not classified	Z-2053-2008	Device Design	Inaccurate measurements when exporting radiography images to Picture Archiving and Communication System (PACS ).

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K982631 (Philips Medical Systems, Inc., 1998) has gone furthest, with 18 descendants of its own.

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	—

https://510kreport.com/device/K920950 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920950: Philips Easyvision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920950

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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