510(k) · Cleared

Cleared

Patriot

K963037510(k) TraditionalCleared Sep 27, 199653-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

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

Cleared on Sep 27, 1996 after a 53-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 41 later devices descend from it.

Decided: Sep 27, 1996
Review: 53 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 0

41 later devices descend from it, 4 citing it directly.

This deviceK963037 PatriotInfimed, Inc. · 1996
Descendant · cites it directly · 33 of its ownK012490 Orion Digital Imaging SystemInfimed, Inc. · 2002
Descendant · 2 generations on · 22 of its ownK093066 I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010
Descendant · 3 generations on · 17 of its ownK103416 Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 2011
Descendant · 4 generations on · 15 of its ownK130318 Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed · 2013
Descendant · 3 generations on · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2001high 5 (2011) · low 0 (2004)2026

Most influential descendants

Showing 5 of 41 · See all

K012490Orion Digital Imaging SystemInfimed, Inc. · 2002 · cites it directly33descendants
K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010 · 2 generations on22descendants
K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 2011 · 3 generations on17descendants
K130318Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed · 2013 · 4 generations on15descendants
K162529DigiX FDXAllengers Medical Systems Limited · 2017 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K963037	Patriot	Infimed, Inc.	1996	—
+1	K012490	Orion Digital Imaging System	Infimed, Inc.	2002	—
+2	K093066	I5 Digital X-Ray Imaging System, Model I5	Infimed, Inc.	2010	—
+3	K103416	Nexus DRF Digital X-Ray Imaging System	Infimed, Inc.	2011	—
+4	K130318	Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)	Varian Medical Systems, X-Ray Products-Infimed	2013	—
+3	K162529	DigiX FDX	Allengers Medical Systems Limited	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	2	0
2006	2	0
2007	1	0
2008	3	0
2010	2	0
2011	5	0
2012	1	0
2013	2	0
2014	1	0
2015	1	0
2016	1	0
2017	3	0
2018	1	0
2019	5	0
2020	2	0
2022	1	0
2023	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K963037, 1996–2026Source: 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

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? (41)

See all 41

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

Number	Device	Applicant	Decided	Descendants
K012490	Orion Digital Imaging System	Infimed, Inc.	2002	33
K011624	Expedio 500D R&F X-Ray System	GE Medical Systems	2001	4
K030544	RFX Fluroscopic Digital Imaging System	Sigma Vision, Inc.	2003	0
K030061	PS 3000 Digatal Photospot System	Precise Optics	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?

Of its descendants, K012490 (Infimed, Inc., 2002) has gone furthest, with 33 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/K963037 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963037: Patriot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963037

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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