510(k) · Cleared
ClearedResolutionmd Mobile Model RMB-Mob-2X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Calgary Scientific, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 9, 2011 after a 119-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Sep 9, 2011
- Review
- 119 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK111346 Resolutionmd Mobile Model RMB-Mob-2XCalgary Scientific, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK123186 Resolutionmd Mobile 3.1 Model RMD-Mob-31Calgary Scientific, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK133508 Resolutionmd MobileCalgary Scientific, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK161130 ResolutionMDCalgary Scientific, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK260500 ResolutionMDResolutionMD, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK183248 Synapse Enterprise Viewer Version 1.0Fujifilm Corporation · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K123186Resolutionmd Mobile 3.1 Model RMD-Mob-31Calgary Scientific, Inc. · 2013 · cites it directly6descendants
- K133508Resolutionmd MobileCalgary Scientific, Inc. · 2014 · cites it directly5descendants
- K161130ResolutionMDCalgary Scientific, Inc. · 2016 · 2 generations on4descendants
- K260500ResolutionMDResolutionMD, Inc. · 2026 · 3 generations on0descendants
- K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111346 | Resolutionmd Mobile Model RMB-Mob-2X | Calgary Scientific, Inc. | 2011 | — |
| +1 | K123186 | Resolutionmd Mobile 3.1 Model RMD-Mob-31 | Calgary Scientific, Inc. | 2013 | — |
| +1 | K133508 | Resolutionmd Mobile | Calgary Scientific, Inc. | 2014 | — |
| +2 | K161130 | ResolutionMD | Calgary Scientific, Inc. | 2016 | — |
| +3 | K260500 | ResolutionMD | ResolutionMD, Inc. | 2026 | — |
| +3 | K183248 | Synapse Enterprise Viewer Version 1.0 | Fujifilm Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
- Of its descendants, K123186 (Calgary Scientific, Inc., 2013) has gone furthest, with 6 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. 2011, 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?
The ResalutionMD' Mobile software isa software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant CT and MR medical images as well as reports on the mobile device. The ResolutionMO Mobile provides wireless and portable access to medical…
Read the full statement (118 words)
The ResalutionMD' Mobile software isa software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant CT and MR medical images as well as reports on the mobile device.
The ResolutionMO Mobile provides wireless and portable access to medical images. The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
The ResolutionMD Mobile is not to be used for mammography.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K111346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111346: Resolutionmd Mobile Model RMB-Mob-2X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111346
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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