510(k) · Cleared
ClearedCONI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globalmed · LLZ System, Image Processing, Radiological
Cleared on May 7, 2013 as substantially equivalent to K081304 (Alz, Inc., 2008) after a 60-day review. Its family tree reaches back 6 generations to 1990. 7 later devices descend from it.
- Decided
- May 7, 2013
- Review
- 60 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. 7 later devices descend from it, 2 citing it directly.
- 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 backK081304 Alz Web Pacs, Version 1.0Alz, Inc. · 2008
- This deviceK130624 CONIGlobalmed · 2013
- Descendant · cites it directly · 4 of its ownK153653 DICOM ViewerBrainlab AG · 2016
- Descendant · 2 generations on · 3 of its ownK191014 Elements ViewerBrainlab AG · 2020
- Descendant · 3 generations on · 1 of its ownK232759 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout…Brainlab AG · 2024 · Recalled
- Descendant · cites it directly · 1 of its ownK132763 Advanced ViewerBrainlab AG · 2014
- Descendant · 3 generations on · 0 of its ownK254265 Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company) · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K153653DICOM ViewerBrainlab AG · 2016 · cites it directly4descendants
- K191014Elements ViewerBrainlab AG · 2020 · 2 generations on3descendants
- K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG · 2024 · 3 generations on1descendant
- K132763Advanced ViewerBrainlab AG · 2014 · cites it directly1descendant
- K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company) · 2026 · 3 generations on0descendants
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 | K081304 | Alz Web Pacs, Version 1.0 | Alz, Inc. | 2008 | — |
| 0 (this device) | K130624 | CONI | Globalmed | 2013 | — |
| +1 | K153653 | DICOM Viewer | Brainlab AG | 2016 | — |
| +2 | K191014 | Elements Viewer | Brainlab AG | 2020 | — |
| +3 | K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements… | Brainlab AG | 2024 | 1 |
| +1 | K132763 | Advanced Viewer | Brainlab AG | 2014 | — |
| +3 | K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K081304 | Alz Web Pacs, Version 1.0Summary page 1…ion Regulation: 892.2050 - Picture Archiving Communication System Product Code: LLZ - System, Image Processing, Radiological Applicant: ALZ, Inc. 510(k) Number: K081304 Device Description: CONi (Capture Over Network Interface) is a secure cloud-based application for viewing and archiving me… | 2008 |
What descends from it? (7)
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 23 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K153653 (Brainlab AG, 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LLZ devicesLLZ 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
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?
CONi provides for the archiving and viewing of medical images from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Single Frame Visible Light Photography (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection.
CONi is not intended for use in mammography.
CONi is not intended for diagnostic use on mobile devices
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130624: CONI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130624
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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