510(k) · Cleared
Recalled · Class II · 2023vRad PACS with Mammography
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 Oct 25, 2016 as substantially equivalent to K112439 (Fujifilm Medical System U.S.A., Inc., 2011) after an 85-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 25, 2016
- Review
- 85 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051553 (2005). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK051553 Fuji Synapse Workstation SoftwareFujifilm Medical Systems U.S.A, Inc. · 2005 · Recalled
- 1 generation backK112439 Synapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc. · 2011 · Recalled
- This deviceK162145 vRad PACS with MammographyVirtual Radiologic Corporation · 2016
- Descendant · cites it directly · 0 of its ownK241879 vRad ViewerVirtual Radiologic Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K241879vRad ViewerVirtual Radiologic Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051553 | Fuji Synapse Workstation Software | Fujifilm Medical Systems U.S.A, Inc. | 2005 | 1 |
| −1 | K112439 | Synapse Workstation Software Version 3.3.0 | Fujifilm Medical System U.S.A., Inc. | 2011 | 2 |
| 0 (this device) | K162145 | vRad PACS with Mammography | Virtual Radiologic Corporation | 2016 | — |
| +1 | K241879 | vRad Viewer | Virtual Radiologic Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K112439 | Synapse Workstation Software Version 3.3.0Summary page 4…Class II Review Panel: Radiology Predicate Device: FujiFilm Medical Systems, Synapse Workstation Software Version 3.3.0, K112439 Device Description: vRad PACS with Mammography is a device which consists solely of software that allows electronic transmissio… | 2011 |
| † | K090649 | Vrad Picture Archiving and Communications System Software | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241879 | vRad Viewer | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2023 | Class II | Z-2235-2023 | Software Manufacturing/Software Deployment | The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K241879 (Virtual Radiologic Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112439.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 PACS with Mammography software is used with general purpose computing hardware which meets or exceeds minimum specifications. vRad PACS with Mammography is intended to receive, transmit, store, and display images for clinical purposes and is comprised of three components: Viewer, Storage, and Cache. The vRad PACS Viewer component is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with…
Read the full statement (215 words)
The vRad PACS with Mammography software is used with general purpose computing hardware which meets or exceeds minimum specifications. vRad PACS with Mammography is intended to receive, transmit, store, and display images for clinical purposes and is comprised of three components: Viewer, Storage, and Cache. The vRad PACS Viewer component is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with vRad PACS Storage component. The vRad 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 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 Storage component is intended to handle the DICOM protocol and store images as DICOM files to a location where they can be read by vRad PACS Cache and transmitted to radiologists' workstations for viewing by the vRad PACS Viewer.
vRad PACS with Mammography 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 displayed on a monitor that meets technical specifications reviewed and cleared by FDA.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162145: vRad PACS with Mammography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162145
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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