510(k) · Cleared
ClearedErad Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erad, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 25, 2006 as substantially equivalent to K013630 (Stentor, Inc., 2001) and 3 other predicates after a 64-day review. Its family tree reaches back 4 generations to 1996. 14 later devices descend from it.
- Decided
- Jul 25, 2006
- Review
- 64 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K954678 (1996). 21 ancestors in all, the oldest K913475 (1991). 14 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK012097 VortexUltravisual Medical Systems · 2001
- This deviceK061421 Erad PacsErad, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK120995 Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK152977 DG PacsDicom Grid, Inc. · 2016 · Recalled
- Descendant · cites it directly · 4 of its ownK132799 Clariso PacsClariso, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK151957 BOX DICOM ViewerBox, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK202335 Ambra ProViewerDicom Grid Inc Dba Ambra Health · 2020 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012 · cites it directly7descendants
- K152977DG PacsDicom Grid, Inc. · 2016 · 2 generations on4descendants
- K132799Clariso PacsClariso, Inc. · 2013 · cites it directly4descendants
- K151957BOX DICOM ViewerBox, Inc. · 2015 · 2 generations on3descendants
- K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K012097 | Vortex | Ultravisual Medical Systems | 2001 | — |
| 0 (this device) | K061421 | Erad Pacs | Erad, Inc. | 2006 | — |
| +1 | K120995 | Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product | Erad, Inc. | 2012 | — |
| +2 | K152977 | DG Pacs | Dicom Grid, Inc. | 2016 | 1 |
| +1 | K132799 | Clariso Pacs | Clariso, Inc. | 2013 | — |
| +2 | K151957 | BOX DICOM Viewer | Box, Inc. | 2015 | — |
| +3 | K202335 | Ambra ProViewer | Dicom Grid Inc Dba Ambra Health | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K013630 | Isite RadiologySummary page 1…tantial Equivalence eRAD PACS has indications for use and a target population similar to other medical image management devices, including Stentor's iSite (K013630) and Stentor's iVault (Class I Exempt), Agfa's IMPAX (K022292), Ultravisual's Vortex (K012097) and Dynamic Imaging'… | 2001 |
| * | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Summary page 1…rget population similar to other medical image management devices, including Stentor's iSite (K013630) and Stentor's iVault (Class I Exempt), Agfa's IMPAX (K022292), Ultravisual's Vortex (K012097) and Dynamic Imaging's INTEGRADWeb MPR/MIP (K042313). All of the functions eRAD PAC… | 2002 |
| * | K012097 | VortexSummary page 1…medical image management devices, including Stentor's iSite (K013630) and Stentor's iVault (Class I Exempt), Agfa's IMPAX (K022292), Ultravisual's Vortex (K012097) and Dynamic Imaging's INTEGRADWeb MPR/MIP (K042313). All of the functions eRAD PACS performs are available in at least on… | 2001 |
| * | K042313 | Integradweb MPR/MipSummary page 1…'s iSite (K013630) and Stentor's iVault (Class I Exempt), Agfa's IMPAX (K022292), Ultravisual's Vortex (K012097) and Dynamic Imaging's INTEGRADWeb MPR/MIP (K042313). All of the functions eRAD PACS performs are available in at least one of the listed substantially equivalent devi… | 2004 |
| * | — | Stentor's iVault Named without a submission number |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K120995 (Erad, Inc., 2012) has gone furthest, with 7 descendants of its own.
- 6 other devices also cite its predicate K013630.
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?
eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. eRAD PACS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061421: Erad Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061421
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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