510(k) · Cleared

Recalled · Class II · 2014

Intelepacs, Model Version 3.X.X

K083520510(k) TraditionalCleared Jun 23, 2009209-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

Intelerad Medical Systems Incorporated · LLZ System, Image Processing, Radiological

Cleared on Jun 23, 2009 after a 209-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled once.

Decided: Jun 23, 2009
Review: 209 days
Class: Class II
Product code: LLZ
Recalls: 1
Predicates: 0

3 later devices descend from it, 1 citing it directly.

This deviceK083520 Intelepacs, Model Version 3.X.XIntelerad Medical Systems Incorporated · 2009
Descendant · cites it directly · 2 of its ownK150707 IntelePACSIntelerad Medical Systems Incorporated · 2015
Descendant · 2 generations on · 0 of its ownK192176 IntelePACSIntelerad Medical Systems Incorporated · 2020 · Recalled
Descendant · 2 generations on · 0 of its ownK162141 Restore PACSXian Wingspan Electronic Technology Co., Ltd. · 2016

Most influential descendants

Showing 3 of 3 · See all

K150707IntelePACSIntelerad Medical Systems Incorporated · 2015 · cites it directly2descendants
K192176IntelePACSIntelerad Medical Systems Incorporated · 2020 · 2 generations on0descendants
K162141Restore PACSXian Wingspan Electronic Technology Co., Ltd. · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K083520	Intelepacs, Model Version 3.X.X	Intelerad Medical Systems Incorporated	2009	—
+1	K150707	IntelePACS	Intelerad Medical Systems Incorporated	2015	—
+2	K192176	IntelePACS	Intelerad Medical Systems Incorporated	2020	3
+2	K162141	Restore PACS	Xian Wingspan Electronic Technology Co., Ltd.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	1	0
2020	1	0

FIG. 1 — Lineage of K083520, 2009–2020Source: 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

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? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150707	IntelePACS	Intelerad Medical Systems Incorporated	2015	2

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 3, 2014	Class II	Z-2267-2014	Software design	In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete.…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K150707 (Intelerad Medical Systems Incorporated, 2015) has gone furthest, with 2 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. 2009, this device’s year, is highlighted.

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/K083520 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083520: Intelepacs, Model Version 3.X.X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083520

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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