510(k) · Cleared
ClearedOrg@Nizer, Model Version 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebit Sanita, S.P.A. · LLZ System, Image Processing, Radiological
Cleared on Mar 27, 2003 as substantially equivalent to K982862 (Applicare Medical Imaging, B.V., 1998) after a 51-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Mar 27, 2003
- Review
- 51 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896095 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 2 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 1 generation backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- This deviceK030363 Org@Nizer, Model Version 3.0Ebit Sanita, S.P.A. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −2 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −1 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| 0 (this device) | K030363 | Org@Nizer, Model Version 3.0 | Ebit Sanita, S.P.A. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K982862 | Radworks Medical Imaging Software with Quality Control ModuleSummary page 1…Predicate Device(s) Applicare Radworks Medical Imaging Software W/ Quality Control Module K982862 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.… | 1998 |
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 13 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- 6 other devices also cite its predicate K982862.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Ebit Sanita Org@nizer software is a medical image management software device intended to be used for digital acquiring, viewing. processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals,after proper installation on an appropriate hardware platform. This medical device is intended for the sole use of digital acquiring, viewing, processing, archiving, reporting and communicating digital ultrasound…
Read the full statement (140 words)
The Ebit Sanita Org@nizer software is a medical image management software device intended to be used for digital acquiring, viewing. processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals,after proper installation on an appropriate hardware platform.
This medical device is intended for the sole use of digital acquiring, viewing, processing, archiving, reporting and communicating digital ultrasound studies. It does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes. The medical device is able to manage stand-alone or distributed medical image archives. It specifically provides the following added-value:
@Connecting diagnostic modalities for the purpose of centralising the image archiving for later image viewing, processing and reporting;
@Establishing distributed points of access on conventional PCs for distributed image and report viewing and access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030363: Org@Nizer, Model Version 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030363
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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