510(k) · Cleared
ClearedvRad Viewer
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 Jul 18, 2024 as substantially equivalent to K162145 (Virtual Radiologic Corporation, 2016) after a 20-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- Jul 18, 2024
- Review
- 20 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K051553 (2005). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK051553 Fuji Synapse Workstation SoftwareFujifilm Medical Systems U.S.A, Inc. · 2005 · Recalled
- 2 generations backK112439 Synapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc. · 2011 · Recalled
- 1 generation backK162145 vRad PACS with MammographyVirtual Radiologic Corporation · 2016 · Recalled
- This deviceK241879 vRad ViewerVirtual Radiologic Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K051553 | Fuji Synapse Workstation Software | Fujifilm Medical Systems U.S.A, Inc. | 2005 | 1 |
| −2 | K112439 | Synapse Workstation Software Version 3.3.0 | Fujifilm Medical System U.S.A., Inc. | 2011 | 2 |
| −1 | K162145 | vRad PACS with Mammography | Virtual Radiologic Corporation | 2016 | 1 |
| 0 (this device) | K241879 | vRad Viewer | Virtual Radiologic Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K162145 | vRad PACS with MammographySummary page 5…K241879 Predicate Device(s): vRad PACS with Mammography (K162145) Device Description: The vRad Viewer is a Software as a Medical Device (SaMD) that imports medical data in the Digital Imaging… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 4 of the 4 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 vRad Viewer software is used with general purpose computing hardware which meets or exceeds minimum specifications. The vRad Viewer is intended to receive, display, and transmit images for clinical purposes. The vRad Viewer is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with storage components. The vRad Viewer is intended to serve as the primary user interface for the processing of…
Read the full statement (154 words)
The vRad Viewer software is used with general purpose computing hardware which meets or exceeds minimum specifications. The vRad Viewer is intended to receive, display, and transmit images for clinical purposes. The vRad Viewer is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with storage components. The vRad 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 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 Viewer may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and may only be used on monitors determined to be appropriate for the desired task.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241879: vRad Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241879
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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