510(k) · Cleared
ClearedVrad Picture Archiving and Communications System Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Virtual Radiologic Corporation · LLZ System, Image Processing, Radiological
Cleared on Mar 27, 2009 as substantially equivalent to K051553 (Fujifilm Medical Systems U.S.A, Inc., 2005) and 1 other predicate after a 16-day review. Its family tree reaches back 3 generations to 2003. 2 later devices descend from it.
- Decided
- Mar 27, 2009
- Review
- 16 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K033712 (2003). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK033712 Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB · 2003
- 2 generations backK040376 Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D…Sectra-Imtec AB · 2004
- 1 generation backK061672 Synapse Mip/MPR Image Visualization Software ObliquusFujifilm Medical Systems U.S.A, Inc. · 2006
- This deviceK090649 Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation · 2009
- Descendant · cites it directly · 1 of its ownK092134 Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK171130 Nucleus Image Management SystemNucleushealth, LLC · 2017
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 |
|---|---|---|---|---|---|
| −3 | K033712 | Modification to Sectra IDS5 Radiology Workstation - Version 10.1 | Sectra-Imtec AB | 2003 | — |
| −2 | K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package | Sectra-Imtec AB | 2004 | — |
| −1 | K061672 | Synapse Mip/MPR Image Visualization Software Obliquus | Fujifilm Medical Systems U.S.A, Inc. | 2006 | — |
| 0 (this device) | K090649 | Vrad Picture Archiving and Communications System Software | Virtual Radiologic Corporation | 2009 | — |
| +1 | K092134 | Stat Pacs Picture Archiving & Communication System (Pacs) | Statrad, LLC | 2009 | — |
| +2 | K171130 | Nucleus Image Management System | Nucleushealth, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K051553 | Fuji Synapse Workstation SoftwareSummary page 1…evice Classification: Class II Predicate Devices: FujiFilm Medical Systems, Synapse Workstation Software, K051553 Fujifilm Medical Systems, Synapse Image Visualization Softw… | 2005 |
| * | K061672 | Synapse Mip/MPR Image Visualization Software ObliquusSummary page 1…Fujifilm Medical Systems, Synapse Image Visualization Software (MIP/MPR) Obliquus, K061672 Device Description: vRad TM PACS is a device which consists solely of software and allows electronic transmission of radiologic… | 2006 |
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 |
|---|---|---|---|
| K092134 | Stat Pacs Picture Archiving & Communication System (Pacs) | 2009 | 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 6 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K092134 (Statrad, LLC, 2009) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K051553.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 vRadTM PACS software is used with general purpose computing hardware, which meets or exceeds minimum specifications. vRadTM PACS software is intended to receive, transmit, store and display images for clinical purposes. The vRad TM PACS Viewer component is intended for installation on an off-the-shelf PC, meeting or exceeding minimum specifications and networked with vRad Tm PACS Storage component. The vRadTM PACS Viewer is intended to serve as the…
Read the full statement (135 words)
The vRadTM PACS software is used with general purpose computing hardware, which meets or exceeds minimum specifications. vRadTM PACS software is intended to receive, transmit, store and display images for clinical purposes. The vRad TM PACS Viewer component is intended for installation on an off-the-shelf PC, meeting or exceeding minimum specifications and networked with vRad Tm PACS Storage component. The vRadTM PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad TM PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM compliant modalities.
The vRad TM PACS system should not be used for Mammography primary image diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090649: Vrad Picture Archiving and Communications System Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090649
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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