510(k) · Cleared
ClearedImageqube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Imaging Informatics, LLC · LLZ System, Image Processing, Radiological
Cleared on Jan 29, 2013 as substantially equivalent to K051037 (Intuitive Imaging Informatics, LLC, 2005) and 3 other predicates after a 29-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jan 29, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K954678 (1996). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK022970 Amicas Light Beam Workstation, Model 1.0Amicas, Inc. · 2002
- 3 generations backK062477 Amicas Vision Series Pacs, Model 4.3Amicas, Inc. · 2006
- 2 generations backK073526 Amicas Vision Series Pacs, Model 5.5Amicas, Inc. · 2008
- 1 generation backK082144 Amicas Pacs, Version 6.0Amicas, Inc. · 2008 · Recalled
- This deviceK124048 ImagequbeIntuitive Imaging Informatics, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K022970 | Amicas Light Beam Workstation, Model 1.0 | Amicas, Inc. | 2002 | — |
| −3 | K062477 | Amicas Vision Series Pacs, Model 4.3 | Amicas, Inc. | 2006 | — |
| −2 | K073526 | Amicas Vision Series Pacs, Model 5.5 | Amicas, Inc. | 2008 | — |
| −1 | K082144 | Amicas Pacs, Version 6.0 | Amicas, Inc. | 2008 | 13 |
| 0 (this device) | K124048 | Imageqube | Intuitive Imaging Informatics, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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? (4)
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 |
|---|---|---|---|
| * | K051037 | Imageqube PacsSummary page 2…teristics between the devices. Modified ImageQube Amicas PACS Candelis Synapse IniageQube (K(051037) 6.0 ImageGrid Obliquus (K(082144) (K(080333)… | 2005 |
| * | K082144 | Amicas Pacs, Version 6.0Summary page 1…892.2050 NUMBER PRODUCT CODE LLZ PREDICATE DEVICES: ImageQube (KOS 1037) Amicas PACS 6.0 (K082 144) Candelis ImageGrid (K080333) Synapse Obliquus MIP/MPRIFusion (K1… | 2008 |
| * | K080333 | ImagegridSummary page 1…LLZ PREDICATE DEVICES: ImageQube (KOS 1037) Amicas PACS 6.0 (K082 144) Candelis ImageGrid (K080333) Synapse Obliquus MIP/MPRIFusion (K1 0088 1) Substantially Equivalent To: The ImageQube is subst… | 2008 |
| * | K100881 | Synapse Obliquus Mip/MPR/FusionSummary page 1…Amicas PACS 6.0 (K082 144) Candelis ImageGrid (K080333) Synapse Obliquus MIP/MPRIFusion (K1 0088 1) Substantially Equivalent To: The ImageQube is substantially equivalent in intended use, principal of operation and technologica… | 2010 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K051037.
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?
ImageQube is intended for use by a physician or other medical professionals in the display and interpretation of medical images and demographic detail from all institutional imaging modalities, including, but not limited to, CT, MRI, NM, DR, US, PET Fusion, Angio and MG (including display of DICOM overlays and 3D Mammography images), along with secondary capture devices, such as film digitizers or other imaging sources. The ImageQube is designed for…
Read the full statement (248 words)
ImageQube is intended for use by a physician or other medical professionals in the display and interpretation of medical images and demographic detail from all institutional imaging modalities, including, but not limited to, CT, MRI, NM, DR, US, PET Fusion, Angio and MG (including display of DICOM overlays and 3D Mammography images), along with secondary capture devices, such as film digitizers or other imaging sources. The ImageQube is designed for display, interpretation, storage and distribution of all modalities.
Only pre-processed DICOM For Presentation images can be interpreted for primary diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be viewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor meeting all the technical specifications required by the FDA for the Performance of Screening and Diagnostic Mammography. Images that are printed to film must be done using an FDA-approved printer for the diagnosis of digital mammography images. Efficient mammography screening makes toolbars and thumbnails available on each monitor, while also handling DICOM overlay display.
Acquired medical images may be displayed and manipulated further utilizing Multi-Planar Reconstruction (MPR), Anatomic Triangulation (AT), Dynamic Cross-Referencing, Maximum Intensity Projection (MWP), Slab and 3-D display, sent to and retrieved by radiologists in-house at facilities or at remote sites, stored, archived or printed. The ImageQube can operate as an independent device, or can also be interfaced with Rational Imaging PACS systems. Annotated print pages, transcribed reports and Key Image Summaries can also be accessed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124048: Imageqube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124048
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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