510(k) · Cleared

Cleared

Isite Radiology

K013630510(k) TraditionalCleared Dec 5, 200130-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

Stentor, Inc. · LLZ System, Image Processing, Radiological

Cleared on Dec 5, 2001 as substantially equivalent to K955092 (Cemax-Icon, Inc., 1996) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1994. 123 later devices descend from it.

Decided: Dec 5, 2001
Review: 30 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K942120 (1994). 2 ancestors in all. 123 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
This deviceK013630 Isite RadiologyStentor, Inc. · 2001
Descendant · cites it directly · 115 of its ownK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
Descendant · 2 generations on · 114 of its ownK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
Descendant · 3 generations on · 56 of its ownK052358 Etiam Star Pacs ComponentsEtiam, S.A. · 2005
Descendant · 4 generations on · 55 of its ownK062488 IQ-System Pacs SystemImage Information Systems, Ltd. · 2006
Descendant · 5 generations on · 49 of its ownK063470 Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007

Showing 5 of 123 descendants. See all descendants

Descendants cleared per year

2003high 12 (2024) · low 1 (2004)2026

Most influential descendants

Showing 5 of 123 · See all

K031311Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003 · cites it directly115descendants
K042313Integradweb MPR/MipDynamic Imaging, Inc. · 2004 · 2 generations on114descendants
K052358Etiam Star Pacs ComponentsEtiam, S.A. · 2005 · 3 generations on56descendants
K062488IQ-System Pacs SystemImage Information Systems, Ltd. · 2006 · 4 generations on55descendants
K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007 · 5 generations on49descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K942120	Advantage Windows Diagnostic X-Ray Workstation	GE Medical Systems	1994	—
0 (this device)	K013630	Isite Radiology	Stentor, Inc.	2001	—
+1	K031311	Integradweb by Dynamic Imaging, Inc.	Dynamic Imaging, Inc.	2003	—
+2	K042313	Integradweb MPR/Mip	Dynamic Imaging, Inc.	2004	—
+3	K052358	Etiam Star Pacs Components	Etiam, S.A.	2005	—
+4	K062488	IQ-System Pacs System	Image Information Systems, Ltd.	2006	—
+5	K063470	Aycan Workstation Osirix	Aycan Digitalsysteme GmbH	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	4	0
2004	1	0
2005	3	0
2006	2	0
2007	2	0
2008	6	0
2009	2	0
2010	6	0
2011	4	0
2012	4	0
2013	3	0
2014	2	0
2015	6	0
2016	7	0
2017	4	0
2018	6	0
2019	2	0
2020	6	0
2021	6	0
2022	5	0
2023	8	0
2024	12	0
2025	11	0
2026	11	0

FIG. 1 — Lineage of K013630, 1994–2026Source: 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 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

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
*	K955092	Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print… Summary page 1 …: Soft-copy reading system Proprietary Name: iSite Radiology 1.5 Substantial Equivalence The iSite Radiology software is substantially equivalent to the Kodak, AutoRad (K955092) and the GE Advantage Windows Diagnostic X-RAY workstation (K942120) product. Page 1 of 1 1.6 1.7 Device Descr…	Cemax-Icon, Inc.	1996	—
*	K942120	Advantage Windows Diagnostic X-Ray Workstation Summary page 1 …stantial Equivalence The iSite Radiology software is substantially equivalent to the Kodak, AutoRad (K955092) and the GE Advantage Windows Diagnostic X-RAY workstation (K942120) product. Page 1 of 1 1.6 1.7 Device Description and Intended Use iSite Radiology is designed as a Diagnostic…	GE Medical Systems	1994	—

Also cleared against K955092: 4 other devices →

What descends from it? (123)

See all 123

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

Number	Device	Applicant	Decided	Descendants
K031311	Integradweb by Dynamic Imaging, Inc.	Dynamic Imaging, Inc.	2003	115
K061421	Erad Pacs	Erad, Inc.	2006	14
K030751	Ipacs Prism	Realtimeimage, Inc.	2003	3
K080290	Xviewnet	American Radiologist Network, Inc.	2008	1
K120305	Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…	Thinking Systems Corp.	2012	0
K032157	Telemis-Medical Solution	Telemis S.A.	2003	0
K031778	Practicebuilder 1-2-3	Erad Imagemedical Corp.	2003	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, K031311 (Dynamic Imaging, Inc., 2003) has gone furthest, with 115 descendants of its own.
4 other devices also cite its predicate K955092.

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?

Stentors’ iSite Radiology is a medical image softcopy reading software package to be used for display of digital radiology images.

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/K013630 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013630: Isite Radiology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013630

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026