510(k) · Cleared
ClearedResolutionmd Mobile
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 Mar 26, 2014 as substantially equivalent to K123186 (Calgary Scientific, Inc., 2013) and 3 other predicates after a 132-day review. Its family tree reaches back 10 generations to 1996. 5 later devices descend from it.
- Decided
- Mar 26, 2014
- Review
- 132 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K954874 (1996). 50 ancestors in all, the oldest K885054 (1989). 5 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 6 generations between
- 3 generations backK062163 MimviewerMimvista Corp. · 2006
- 2 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 1 generation backK112930 Mobile MimMim Software, Inc. · 2011
- This deviceK133508 Resolutionmd MobileCalgary Scientific, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK161130 ResolutionMDCalgary Scientific, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK260500 ResolutionMDResolutionMD, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK183248 Synapse Enterprise Viewer Version 1.0Fujifilm Corporation · 2019
- Descendant · 2 generations on · 0 of its ownK181185 Change Healthcare Enterprise ViewerChange Healthcare Canada Company · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK162655 StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 9 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 8 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 7 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 6 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 5 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 4 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 3 generations backK062163 MimviewerMimvista Corp. · 2006
- 2 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 1 generation backK112930 Mobile MimMim Software, Inc. · 2011
- This deviceK133508 Resolutionmd MobileCalgary Scientific, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K161130ResolutionMDCalgary Scientific, Inc. · 2016 · cites it directly4descendants
- K260500ResolutionMDResolutionMD, Inc. · 2026 · 2 generations on0descendants
- K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation · 2019 · 2 generations on0descendants
- K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company · 2018 · 2 generations on0descendants
- K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −9 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −8 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −7 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −6 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −5 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −4 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −3 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −2 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −1 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| 0 (this device) | K133508 | Resolutionmd Mobile | Calgary Scientific, Inc. | 2014 | — |
| +1 | K161130 | ResolutionMD | Calgary Scientific, Inc. | 2016 | — |
| +2 | K260500 | ResolutionMD | ResolutionMD, Inc. | 2026 | — |
| +2 | K183248 | Synapse Enterprise Viewer Version 1.0 | Fujifilm Corporation | 2019 | — |
| +2 | K181185 | Change Healthcare Enterprise Viewer | Change Healthcare Canada Company | 2018 | 2 |
| +2 | K162655 | StealthConnect Remote Viewing, Planning and Collaboration System | Medtronic Navigation, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K123186 | Resolutionmd Mobile 3.1 Model RMD-Mob-31Summary page 1…valence is claimed: Device Manufacturer 510(k) Number ResolutionMD Mobile 3.1 Calgary Scientific Inc. K123186 ResolutionMD Mobile Calgary Scientific Inc. K111346 Mobile MIM MIM Software Inc.… | 2013 |
| * | K111346 | Resolutionmd Mobile Model RMB-Mob-2XSummary page 1…510(k) Number ResolutionMD Mobile 3.1 Calgary Scientific Inc. K123186 ResolutionMD Mobile Calgary Scientific Inc. K111346 Mobile MIM MIM Software Inc. K112930 Centricity PACS GE Healthcare… | 2011 |
| * | K112930 | Mobile MimSummary page 1…fic Inc. K123186 ResolutionMD Mobile Calgary Scientific Inc. K111346 Mobile MIM MIM Software Inc. K112930 Centricity PACS GE Healthcare K110875 K133508 510(k) Su… | 2011 |
| * | K110875 | Centricity PacsSummary page 1…fic Inc. K111346 Mobile MIM MIM Software Inc. K112930 Centricity PACS GE Healthcare K110875 K133508 510(k) Summary Page 1 of 4 Device Descrip… | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161130 | ResolutionMD | 2016 | 4 |
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 18 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 50 ancestors have a recall of any class.
- Of its descendants, K161130 (Calgary Scientific, Inc., 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. 2014, 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?
ResolutionMDM Mobile is a 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 medical images as well as reports on the mobile device. ResolutionMD Mobile provides wireless and portable access to medical images. The device is…
Read the full statement (112 words)
ResolutionMDM Mobile is a 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 medical images as well as reports on the mobile device.
ResolutionMD 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.
ResolutionMD Mobile is not to be used for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133508: Resolutionmd Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133508
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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