510(k) · Cleared
ClearedEzpacs, Version 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Imaging Solutions, LLC · LLZ System, Image Processing, Radiological
Cleared on Jun 27, 2007 as substantially equivalent to K030781 (Eastman Kodak Company, 2003) and 1 other predicate after a 274-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Jun 27, 2007
- Review
- 274 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913475 (1991). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 3 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 2 generations backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- 1 generation backK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
- This deviceK062878 Ezpacs, Version 3.0Advanced Imaging Solutions, LLC · 2007
- Descendant · cites it directly · 1 of its ownK100236 Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK112008 Touchpacs SuiteTouch Medical Solutions, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −3 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −2 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| −1 | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for… | Agfa Corp. | 2002 | 9 |
| 0 (this device) | K062878 | Ezpacs, Version 3.0 | Advanced Imaging Solutions, LLC | 2007 | — |
| +1 | K100236 | Stair Systems Pacs & Dicom Viewer | Stair Systems, Inc. | 2010 | — |
| +1 | K112008 | Touchpacs Suite | Touch Medical Solutions, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K030781 | Kodak Directview Pacs/Image Management System, Kodak Directview Workflow Manager,Kodak…Summary page 1…n Name: Picture Archiving Communications System (PACS) Classification: Class II (Product Code: LLZ) Predicate Devices DirectView by Kodak (K030781 approved 5/29/03) IMPAX by Agfa (K022292 approved 9/12/02) Description of Device EZPACSO is a PACS system that ru… | 2003 |
| * | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Summary page 1…s System (PACS) Classification: Class II (Product Code: LLZ) Predicate Devices DirectView by Kodak (K030781 approved 5/29/03) IMPAX by Agfa (K022292 approved 9/12/02) Description of Device EZPACSO is a PACS system that runs on off-the-shelf monitors and PCs runn… | 2002 |
What descends from it? (2)
2 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 4.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K100236 (Stair Systems, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K030781.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
EZPACS® is intended for use by radiologists (for primary diagnosis), and other medical professionals who needs access to radiological images and reports.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062878 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062878: Ezpacs, Version 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062878
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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