510(k) · Cleared
ClearedOmni-Vue System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Digital Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 10, 2008 as substantially equivalent to K042311 (Medical Standard Co., Ltd., 2004) after a 132-day review. Its family tree reaches back 4 generations to 2001. 3 later devices descend from it.
- Decided
- Mar 10, 2008
- Review
- 132 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010259 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 3 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 2 generations backK023460 PacsplusMedical Standard Co., Ltd. · 2003
- 1 generation backK042311 PacspartnerMedical Standard Co., Ltd. · 2004
- This deviceK073062 Omni-Vue SystemGenesis Digital Imaging, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK092235 Beyondimage WorkstationNeusoft Medical Systems Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK130374 Omni-Vue 2 SystemGenesis Digital Imaging, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK102435 Beyondimage WorkstationNeusoft Medical Systems Co., Ltd. · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −3 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −2 | K023460 | Pacsplus | Medical Standard Co., Ltd. | 2003 | — |
| −1 | K042311 | Pacspartner | Medical Standard Co., Ltd. | 2004 | — |
| 0 (this device) | K073062 | Omni-Vue System | Genesis Digital Imaging, Inc. | 2008 | — |
| +1 | K092235 | Beyondimage Workstation | Neusoft Medical Systems Co., Ltd. | 2009 | — |
| +1 | K130374 | Omni-Vue 2 System | Genesis Digital Imaging, Inc. | 2013 | — |
| +2 | K102435 | Beyondimage Workstation | Neusoft Medical Systems Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K042311 | PacspartnerSummary page 1…icate Device: 21 CFR 807. 92(a)(3) Device Classification Name system, image processing, radiological 510(k) Number K042311 Regulation Number 892.2050 Class II Device Name PACSPartnerTM… | 2004 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K092235 (Neusoft Medical Systems Co., Ltd., 2009) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K042311.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 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-VueTM System is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F 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 (229 words)
Omni-VueTM System is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F 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 reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. The Omni-Vue device allows limited image processing capability: "sharpening preset" and window leveling function. For image editing; the only an "L"or "R"marker can be added to the image but it must be already defined in the original image DICOM header as received by the system. "L"or "R"can not be added to the image if left & right is not defined in the original image. The device provides scout line which is a reference line and is drawn on the AP image to display the location of the slice being viewed. In multi series images, whenever one image is clicked, scout line will be drawn on other series which is crossed direction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073062 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073062: Omni-Vue System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073062
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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