510(k) · Cleared
ClearedOpenRad Cloud
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Openrad Services Uk, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Apr 24, 2024 as substantially equivalent to K063107 (Biotronics3D, Ltd., 2006) and 1 other predicate after a 28-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Apr 24, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K942120 (1994). 32 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.
- Root · 9 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 5 generations between
- 3 generations backK063470 Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007
- 2 generations backK101342 Osirix MDPixmeo Sarl · 2010
- 1 generation backK202335 Ambra ProViewerDicom Grid Inc Dba Ambra Health · 2020 · Recalled
- This deviceK240839 OpenRad CloudOpenrad Services Uk, Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 8 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 7 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 6 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 5 generations backK052358 Etiam Star Pacs ComponentsEtiam, S.A. · 2005
- 4 generations backK062488 IQ-System Pacs SystemImage Information Systems, Ltd. · 2006
- 3 generations backK063470 Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007
- 2 generations backK101342 Osirix MDPixmeo Sarl · 2010
- 1 generation backK202335 Ambra ProViewerDicom Grid Inc Dba Ambra Health · 2020 · Recalled
- This deviceK240839 OpenRad CloudOpenrad Services Uk, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −8 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −7 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −6 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −5 | K052358 | Etiam Star Pacs Components | Etiam, S.A. | 2005 | — |
| −4 | K062488 | IQ-System Pacs System | Image Information Systems, Ltd. | 2006 | — |
| −3 | K063470 | Aycan Workstation Osirix | Aycan Digitalsysteme GmbH | 2007 | — |
| −2 | K101342 | Osirix MD | Pixmeo Sarl | 2010 | — |
| −1 | K202335 | Ambra ProViewer | Dicom Grid Inc Dba Ambra Health | 2020 | 1 |
| 0 (this device) | K240839 | OpenRad Cloud | Openrad Services Uk, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K063107 | 3DNET SuiteSummary page 4…PREDICATE DEVICES: Primary Predicate Device: Manufacturer: Biotronics3D, Trade name: 3Dnet Suite, Premarket No9fica9on #: K063107 Device Product Code & Regula9on #: LLZ; 21 CFR 892.2050 Reference Predicate Device: Manufactur… | 2006 |
| * | K202335 | Ambra ProViewerSummary page 4…vice: Manufacturer: Dicom Grid, Inc., dba Ambra Health, Trade name: Ambra PACS including Ambra ProViewer Premarket No9fica9on #: K202335 Device Product Code & Regula9on #: LLZ; 21 CFR 892.2050 4. DEVICE DESCRIPTION The OpenRad Cloud is a so^ware… | 2020 |
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 30 years and passes through 9 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 32 ancestors have a recall of any class.
- 2 other devices also cite its predicate K063107.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
OpenRad Cloud PACS and Viewer is intended for use in the medical image analysis and diagnosis workflows of hospitals, imaging centres, radiologists, reading practices and any user who requires and is granted access to a patient image and associated demographic and report information, including Peer Review or Teleradiology providers. OpenRad Cloud PACS Viewer displays, modifies, and manages diagnostic quality DICOM images, including 3D visualisation and…
Read the full statement (140 words)
OpenRad Cloud PACS and Viewer is intended for use in the medical image analysis and diagnosis workflows of hospitals, imaging centres, radiologists, reading practices and any user who requires and is granted access to a patient image and associated demographic and report information, including Peer Review or Teleradiology providers. OpenRad Cloud PACS Viewer displays, modifies, and manages diagnostic quality DICOM images, including 3D visualisation and reordering functionality.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography display.
The device is not intended for use with mobile displays. Review of images require an optimum display of images. Only use cleared monitors and printers for diagnosis review of images. Follow the maintenance and care instructions given in the manufacturer’s documentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240839 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240839: OpenRad Cloud.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240839
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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