510(k) · Cleared

Cleared

Omni-Vue 2 System

K130374510(k) SpecialCleared Aug 29, 2013196-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

Genesis Digital Imaging, Inc. · LLZ System, Image Processing, Radiological

Cleared on Aug 29, 2013 as substantially equivalent to K073062 (Genesis Digital Imaging, Inc., 2008) after a 196-day review. Its family tree reaches back 5 generations to 2001.

Decided: Aug 29, 2013
Review: 196 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K010259 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
4 generations backK012844 Marosis PacsMarotech, Inc. · 2001
3 generations backK023460 PacsplusMedical Standard Co., Ltd. · 2003
2 generations backK042311 PacspartnerMedical Standard Co., Ltd. · 2004
1 generation backK073062 Omni-Vue SystemGenesis Digital Imaging, Inc. · 2008
This deviceK130374 Omni-Vue 2 SystemGenesis Digital Imaging, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K010259	Mediface Pacs	Mediface Co., Ltd.	2001	—
−4	K012844	Marosis Pacs	Marotech, Inc.	2001	—
−3	K023460	Pacsplus	Medical Standard Co., Ltd.	2003	—
−2	K042311	Pacspartner	Medical Standard Co., Ltd.	2004	—
−1	K073062	Omni-Vue System	Genesis Digital Imaging, Inc.	2008	—
0 (this device)	K130374	Omni-Vue 2 System	Genesis Digital Imaging, Inc.	2013	—

FIG. 1 — Lineage of K130374, 2001–2013Source: 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
*	K073062	Omni-Vue System Summary page 1 …dicate Device: 21 CER 807. 92(a)(3) Device Classification Name system, image processing, radiological 20 510(K) Number K073062 Device Name OMNI-VUE SYSTEM Applicant GENESIS DIGITAL IMAGI…	Genesis Digital Imaging, Inc.	2008	—

Also cleared against K073062: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
None of the 5 ancestors has a recall.
1 other device also cites its predicate K073062.

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. 2013, 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	—

What is it indicated for?

Omni-Vue 2Tm System is a software device that receives digital images and data from various sources (eg. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Device options make possible…

Read the full statement (111 words)

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by FDA

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130374 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130374: Omni-Vue 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130374

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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