510(k) · Cleared

Cleared

Omnivision

K110040510(k) TraditionalCleared Jan 26, 201120-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

Modern Module, Inc. · LLZ System, Image Processing, Radiological

Cleared on Jan 26, 2011 as substantially equivalent to K070618 (Oehm Und Rehbein GmbH, 2007) after a 20-day review. Its family tree reaches back 6 generations to 1990. 15 later devices descend from it.

Decided: Jan 26, 2011
Review: 20 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to K896095 (1990). 8 ancestors in all. 15 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 6 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
5 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
4 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
3 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
2 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
1 generation backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
This deviceK110040 OmnivisionModern Module, Inc. · 2011
Descendant · cites it directly · 14 of its ownK112132 Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011
Descendant · 2 generations on · 11 of its ownK130883 Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013
Descendant · 3 generations on · 7 of its ownK140825 Delworks DR SystemDel Medical, Inc. · 2014
Descendant · 3 generations on · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
Descendant · 4 generations on · 5 of its ownK192541 DigiX FDXAllengers Medical Systems Limited · 2019

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2011high 2 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 15 · See all

K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011 · cites it directly14descendants
K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013 · 2 generations on11descendants
K140825Delworks DR SystemDel Medical, Inc. · 2014 · 3 generations on7descendants
K162529DigiX FDXAllengers Medical Systems Limited · 2017 · 3 generations on6descendants
K192541DigiX FDXAllengers Medical Systems Limited · 2019 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K896095	Images-on-Call Teleradiology System	Devices & Services Co.	1990	—
−5	K962699	Radworks Medical Imaging Software	Applicare Medical Imaging, B.V.	1996	—
−4	K982862	Radworks Medical Imaging Software with Quality Control Module	Applicare Medical Imaging, B.V.	1998	—
−3	K012211	Efilm Workstation	Efilm Medical, Inc.	2001	1
−2	K020995	Efilm Workstation with Modules	Efilm Medical, Inc.	2002	2
−1	K070618	Dicompacs, Model 5	Oehm Und Rehbein GmbH	2007	—
0 (this device)	K110040	Omnivision	Modern Module, Inc.	2011	—
+1	K112132	Krystalrad 660 Digital Radiographic Portable Retrofit System	Medicatech USA	2011	—
+2	K130883	Sedecal Digital Radiographic Upgrade Model Sdru-T	Sedecal., Sa.	2013	—
+3	K140825	Delworks DR System	Del Medical, Inc.	2014	—
+3	K162529	DigiX FDX	Allengers Medical Systems Limited	2017	—
+4	K192541	DigiX FDX	Allengers Medical Systems Limited	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	2	0
2014	1	0
2017	1	0
2019	1	0
2020	1	0
2021	2	0
2022	1	0
2023	2	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K110040, 1990–2026Source: 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? (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
*	K070618	Dicompacs, Model 5 Summary page 1 …evice Classification Class 11 Product code LLZ Manufacturer Oehm und Rehbein GmbH 510(k) number IK070618 000019 510O(k) Premark…	Oehm Und Rehbein GmbH	2007	—

Also cleared against K070618: 4 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K112132	Krystalrad 660 Digital Radiographic Portable Retrofit System	Medicatech USA	2011	14

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 21 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
2 of the 8 ancestors have a recall of any class.
Of its descendants, K112132 (Medicatech USA, 2011) has gone furthest, with 14 descendants of its own.
4 other devices also cite its predicate K070618.

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. 2011, 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?

OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical Images. OmniVision receives imaiges from imaging modalities via DICOM or imported directly. It archives and displays these images for the use of medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images.

It provides the user with a range of tools to assist them in viewing the images, such as zoom. filters and measurements, and with facilities to exchange images with other specialists.

OmniVision is not intended for the acquisition of mammographic image data.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110040 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110040: Omnivision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110040

Report an extraction error

Are you the manufacturer?

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