510(k) · Cleared
ClearedErad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product
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 Dec 3, 2012 as substantially equivalent to K061421 (Erad, Inc., 2006) after a 245-day review. Its family tree reaches back 5 generations to 1996. 7 later devices descend from it.
- Decided
- Dec 3, 2012
- Review
- 245 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954678 (1996). 22 ancestors in all, the oldest K913475 (1991). 7 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK012097 VortexUltravisual Medical Systems · 2001
- 1 generation backK061421 Erad PacsErad, Inc. · 2006
- This deviceK120995 Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK152977 DG PacsDicom Grid, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK202335 Ambra ProViewerDicom Grid Inc Dba Ambra Health · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK241223 eRAD PACSErad, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK240839 OpenRad CloudOpenrad Services Uk, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK231360 Ambra PACSDicom Grid Dba Ambra Health · 2023 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152977DG PacsDicom Grid, Inc. · 2016 · cites it directly4descendants
- K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health · 2020 · 2 generations on2descendants
- K241223eRAD PACSErad, Inc. · 2024 · cites it directly0descendants
- K240839OpenRad CloudOpenrad Services Uk, Ltd. · 2024 · 3 generations on0descendants
- K231360Ambra PACSDicom Grid Dba Ambra Health · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K012097 | Vortex | Ultravisual Medical Systems | 2001 | — |
| −1 | K061421 | Erad Pacs | Erad, Inc. | 2006 | — |
| 0 (this device) | K120995 | Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product | Erad, Inc. | 2012 | — |
| +1 | K152977 | DG Pacs | Dicom Grid, Inc. | 2016 | 1 |
| +2 | K202335 | Ambra ProViewer | Dicom Grid Inc Dba Ambra Health | 2020 | 1 |
| +1 | K241223 | eRAD PACS | Erad, Inc. | 2024 | — |
| +3 | K240839 | OpenRad Cloud | Openrad Services Uk, Ltd. | 2024 | — |
| +3 | K231360 | Ambra PACS | Dicom Grid Dba Ambra Health | 2023 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K061421 | Erad PacsSummary page 1…Image Processing, Radiological Common Name: PACS, Proprietary Name: eRAD PACS and eRAD RIS/PACS Predicate Devices: eRAD PACS- #K061421I(July 25, 2006) Device Description: eRAIJ PACS! eRAD RIS/PACS Software Product is a PACS system, comprised of acquisition compo… | 2006 |
What descends from it? (7)
3 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 16 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K152977 (Dicom Grid, Inc., 2016) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K061421.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
eRAD PACS! eRAD RIS/PACS is a PACS software product used to receive DICOM images, scheduling information and textual report, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. The eRAD PACS! eRAD RIS/PACS viewer software is intended for use as a primary diagnostic and analysis tool for diagnostic images. eRAD PACS! eRAD RIS/PACS is for hospitals, imaging centers…
Read the full statement (165 words)
eRAD PACS! eRAD RIS/PACS is a PACS software product used to receive DICOM images, scheduling information and textual report, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces.
The eRAD PACS! eRAD RIS/PACS viewer software is intended for use as a primary diagnostic and analysis tool for diagnostic images. eRAD PACS! eRAD RIS/PACS is for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
The eRAD PACS! eRAD RIS/PACS viewer displays images from CT, computed radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light modalities.
Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120995: Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120995
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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