510(k) · Cleared
ClearedImagegrid Radiology Viewer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candelis, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 8, 2009 after a 14-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Oct 8, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK092949 Imagegrid Radiology Viewer SystemCandelis, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK111694 ASTRACandelis, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK140960 Picture Archiving and Communications SystemHologic, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK190694 Unifi Workspace v1.0.0Hologic, Inc. · 2019
- Descendant · 4 generations on · 1 of its ownK220767 TeleScanBb Imaging · 2022
- Descendant · cites it directly · 0 of its ownK262143 ImageGrid StreamVueCandelis, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K111694ASTRACandelis, Inc. · 2011 · cites it directly5descendants
- K140960Picture Archiving and Communications SystemHologic, Inc. · 2014 · 2 generations on3descendants
- K190694Unifi Workspace v1.0.0Hologic, Inc. · 2019 · 3 generations on2descendants
- K220767TeleScanBb Imaging · 2022 · 4 generations on1descendant
- K262143ImageGrid StreamVueCandelis, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092949 | Imagegrid Radiology Viewer System | Candelis, Inc. | 2009 | — |
| +1 | K111694 | ASTRA | Candelis, Inc. | 2011 | — |
| +2 | K140960 | Picture Archiving and Communications System | Hologic, Inc. | 2014 | — |
| +3 | K190694 | Unifi Workspace v1.0.0 | Hologic, Inc. | 2019 | — |
| +4 | K220767 | TeleScan | Bb Imaging | 2022 | — |
| +1 | K262143 | ImageGrid StreamVue | Candelis, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | — | Imagegrid Named without a submission number | |
| * | — | Integradweb Named without a submission number |
What descends from it? (8)
3 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?
- Of its descendants, K111694 (Candelis, Inc., 2011) has gone furthest, with 5 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. 2009, 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?
ImageGrid Radiology Viewer SystemTM is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for…
Read the full statement (135 words)
ImageGrid Radiology Viewer SystemTM is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may 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.
Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092949: Imagegrid Radiology Viewer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092949
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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