510(k) · Cleared
ClearedResolutionmd, Version 1.3
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 22, 2006 as substantially equivalent to K050033 (Mevisys Co., Ltd., 2005) and 2 other predicates after a 56-day review. Its family tree reaches back 5 generations to 1991. 2 later devices descend from it.
- Decided
- Sep 22, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K913770 (1991). 20 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 1 generation backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- This deviceK062164 Resolutionmd, Version 1.3Calgary Scientific, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK100236 Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK112008 Touchpacs SuiteTouch Medical Solutions, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −1 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| 0 (this device) | K062164 | Resolutionmd, Version 1.3 | Calgary Scientific, Inc. | 2006 | — |
| +1 | K100236 | Stair Systems Pacs & Dicom Viewer | Stair Systems, Inc. | 2010 | — |
| +2 | K112008 | Touchpacs Suite | Touch Medical Solutions, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K050033 | LucionSummary page 1…Product Code LLZ, (Class II) Substantially Tradename: Lucion Equivalent to: Manufacturer: Mevisys 5 10(k) Number: K050033 Tradename: Plug 'n View 3D Manufacturer: Voxar Limited… | 2005 |
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 1…Number: K050033 Tradename: Plug 'n View 3D Manufacturer: Voxar Limited 5 10(k) Number: K992654 Tradename: Vitrea 2 Manufacturer: Vital Images, Inc.… | 1999 |
| * | K032748 | VITREA2, Version 3.4 Medical Image Processing SoftwareSummary page 1…(k) Number: K992654 Tradename: Vitrea 2 Manufacturer: Vital Images, Inc. 510(k) Number: K032748 Device Description: ResolutionMDTM is a software based Picture Archiving and Communication System (PACS) used with general pur… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100236 | Stair Systems Pacs & Dicom Viewer | 2010 | 1 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K100236 (Stair Systems, Inc., 2010) has gone furthest, with 1 descendant 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.
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?
ResolutionMDTM is a 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, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. ResolutionMDTM is intended for use as a diagnostic, review, and analysis tool by trained professionals such…
Read the full statement (157 words)
ResolutionMDTM is a 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, processing,
rendering, and display of DICOM 3.0 compliant image data derived from various sources
including CT and MRI.
ResolutionMDTM 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 is the user's
responsibility to ensure that the software is installed on appropriate hardware and that
image quality is suitable for the clinical application.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062164: Resolutionmd, Version 1.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062164
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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