510(k) · Cleared
Recalled · Class II · 2017DR Systems Zero Download 3D Viewer (Z3D)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 10, 2015 as substantially equivalent to K060505 (Barcoview Mis Edinburgh, 2006) after a 111-day review. Its family tree reaches back 1 generation to 2006. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 10, 2015
- Review
- 111 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060505 (2006). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK060505 Voxar 3D Enterprise, Model 6.1Barcoview Mis Edinburgh · 2006
- This deviceK143318 DR Systems Zero Download 3D Viewer (Z3D)Dr Systems, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK182290 IBM iConnect AccessMerge Healthcare Incorporated · 2018
- Descendant · 2 generations on · 2 of its ownK203104 IBM iConnect AccessMerge Healthcare Incorporated · 2021
- Descendant · 3 generations on · 0 of its ownK254237 Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl. · 2026
- Descendant · 3 generations on · 0 of its ownK250301 Merge Universal Viewer (MUV)Merge Healthcare Incorporated · 2025
Most influential descendants
Showing 4 of 4 · See all- K182290IBM iConnect AccessMerge Healthcare Incorporated · 2018 · cites it directly3descendants
- K203104IBM iConnect AccessMerge Healthcare Incorporated · 2021 · 2 generations on2descendants
- K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl. · 2026 · 3 generations on0descendants
- K250301Merge Universal Viewer (MUV)Merge Healthcare Incorporated · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060505 | Voxar 3D Enterprise, Model 6.1 | Barcoview Mis Edinburgh | 2006 | — |
| 0 (this device) | K143318 | DR Systems Zero Download 3D Viewer (Z3D) | Dr Systems, Inc. | 2015 | — |
| +1 | K182290 | IBM iConnect Access | Merge Healthcare Incorporated | 2018 | — |
| +2 | K203104 | IBM iConnect Access | Merge Healthcare Incorporated | 2021 | — |
| +3 | K254237 | Cci Pacs Viewer (Pacs-US-001) | CliniComp, Intl. | 2026 | — |
| +3 | K250301 | Merge Universal Viewer (MUV) | Merge Healthcare Incorporated | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K060505 | Voxar 3D Enterprise, Model 6.1Summary page 4…ation Name: Systems, Image processing, Radiological Classification 21 CFR 892.2050, Class II Regulation: Product Code: 90 LLZ Predicate Device: K060505 - Voxar 3D Product Family Device Description: DR Systems Z3D (Zero Download 3D) advanced imaging solution supports… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182290 | IBM iConnect Access | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2017 | Class II | Z-3105-2017 | Process design | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. |
| Aug 7, 2017 | Class II | Z-2566-2018 | Process design | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
DR Systems Z3D is intended to provide reading physicians, referring physicians, and other appropriate healthcare professionals tools to aid in interpreting medical images, including: • Displaying DICOM compliant medical image volumes, such as CT, MRI, and PET. • Reformatting images, including creation of MPRs, MIPS, MinIPs, color/monochrome 3D volume rendered images • Manipulating displayed images via control of slice thickness, slice interval…
Read the full statement (136 words)
DR Systems Z3D is intended to provide reading physicians, referring physicians, and other appropriate healthcare professionals tools to aid in interpreting medical images, including:
• Displaying DICOM compliant medical image volumes, such as CT, MRI, and PET.
• Reformatting images, including creation of MPRs, MIPS, MinIPs, color/monochrome 3D volume rendered images
• Manipulating displayed images via control of slice thickness, slice interval, obliquity, perspective, rotation, window/level, crop, zoom, color/monochrome transformations, segmentation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.
• Creating series of DICOM images and individually captured images that can be displayed and stored in a PACS.
• Measuring coronary calcium, which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143318: DR Systems Zero Download 3D Viewer (Z3D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143318
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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