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 Oct 31, 2024 as substantially equivalent to K120995 (Erad, Inc., 2012) after a 183-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Oct 31, 2024
- Review
- 183 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 23 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK012097 VortexUltravisual Medical Systems · 2001
- 2 generations backK061421 Erad PacsErad, Inc. · 2006
- 1 generation backK120995 Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012
- This deviceK241223 eRAD PACSErad, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K012097 | Vortex | Ultravisual Medical Systems | 2001 | — |
| −2 | K061421 | Erad Pacs | Erad, Inc. | 2006 | — |
| −1 | K120995 | Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product | Erad, Inc. | 2012 | — |
| 0 (this device) | K241223 | eRAD PACS | Erad, Inc. | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K120995 | Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductSummary page 5…e: System, Image Processing, Radiological Common Name: MIMPS, PACS Proprietary Name: eRAD PACS Predicate Devices: eRAD PACS, #K120995 (December 3, 2012) Device Description: eRAD PACS is a software-only medical image management and processing system, comprised o… | 2012 |
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 28 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 23 ancestors have a recall of any class.
- 2 other devices also cite its predicate K120995.
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?
eRAD PACS is a software-only medical device used to receive medical images, scheduling information and clinical reports, organize and store them in an internal format, and make the information available across a network via web and customized user interfaces. eRAD PACS includes software intended for use by qualified professionals for the presentation, review and comparison of diagnostic medical images. eRAD PACS is for hospitals, imaging centers, reading…
Read the full statement (157 words)
eRAD PACS is a software-only medical device used to receive medical images, scheduling information and clinical reports, organize and store them in an internal format, and make the information available across a network via web and customized user interfaces.
eRAD PACS includes software intended for use by qualified professionals for the presentation, review and comparison of diagnostic medical images.
eRAD PACS is for hospitals, imaging centers, reading practices, radiologists, technicians, physicians and other users who require and are granted access to patient image, exam and report information.
The eRAD PACS viewer displays images from DICOM compliant modalities and other devices including CT, computed and digital radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light systems.
Lossy compressed images and digitized film images must not be used for primary diagnosis of mammography studies. When displaying mammography images for clinical interpretation, only monitors having regulatory clearance for mammography interpretation should be used.
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/K241223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241223: 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/K241223
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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