510(k) · Cleared
ClearedResolutionmd Web
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 Apr 19, 2012 after a 100-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Apr 19, 2012
- Review
- 100 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK120076 Resolutionmd WebCalgary Scientific, Inc. · 2012
- 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
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 |
|---|---|---|---|---|---|
| 0 (this device) | K120076 | Resolutionmd Web | Calgary Scientific, Inc. | 2012 | — |
| +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 | — |
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 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? (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?
- 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. 2012, 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 ResolutionMD(TM) isa software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionlMD software is intended for use as adiagnostic, review, and analysis tool by trained…
Read the full statement (720 words)
The ResolutionMD(TM) isa software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
The ResolutionlMD software is intended for use as adiagnostic, review, and analysis tool by trained professionals such as physicians, technologists and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It isthe user's responsibility to ensure that the software is installed on appropriate hardware and that *image quality issuitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMVD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.
*ResolutionMVD Web 2.9 is not to be used for mammography.
The ResolutionMD(TM) isa software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
The ResolutionMVD device incorporates a Calcium Scoring module which isused to identify and quantify calcified plaque within the coronary arteries. This protocol isperformed on non-contrast enhanced cardiac CT data sets.
The ResolutionMD software isintended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It isthe user's responsibility to ensure that the software isinstalled on appropriate hardware and that image quality is suitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.
ResolutionlMO Web 2.9 isnot to be used for mammography.
The Resolution MD(TM) isa software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
The ResolutionIVI device incorporates a Coronary Analysis protocol which isused to visually identify and measure stenoses in the coronary arteries. This protocol isperformed on contrast-enhanced cardiac CTA data sets.
The Resolution!MD software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It isthe user's responsibility to ensure that the software isinstalled on appropriate hardware and that image quality issuitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.
ResolutionMOI Web 2.9 isnot to be used for mammography.
ResolutionMD TMWeb 2.9 isa software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
ResolutionMD Web 2.9 incorporates a Vessel Analysis module which is used as a post-processing diagnostic review and analysis application for images viewed from ResolutionMD T, a PACS workstation or DICOM image viewer. It is atool for use by trained professionals such as physicians, technologists and surgeons to review, edit, analyze and report findings of vascular anatomy. Clinicians can semi-automatically determine contrasted lumen boundaries and stenosis measurements, and evaluate maximum and minimum lumen diameters and length measurements.
ResolutionMD Web 2.9 isintended for use as a diagnostic, review, and analysis tool by train ed professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It isthe user's responsibility to. ensure that the software isinstalled on appropriate hardware and that image quality issuitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMD Web 2.9 consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.
ResolutionMD Web 2.9 isnot to be used for mammography.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K120076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120076: Resolutionmd Web.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120076
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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