510(k) · Cleared
ClearedApax Pacs System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tis, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 17, 2003 as substantially equivalent to K010259 (Mediface Co., Ltd., 2001) after a 12-day review. Its family tree reaches back 1 generation to 2001. 19 later devices descend from it.
- Decided
- Sep 17, 2003
- Review
- 12 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010259 (2001). 19 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010259 Mediface PacsMediface Co., Ltd. · 2001
- This deviceK032760 Apax Pacs SystemTis, Inc. · 2003
- Descendant · cites it directly · 14 of its ownK070464 ONDEMAND3DCybermed, Inc. · 2007
- Descendant · 2 generations on · 9 of its ownK113543 ONDEMAND3DCybermed, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK131616 EZ3D-I, E3Ewoosoft Co., Ltd. · 2013
- Descendant · 4 generations on · 3 of its ownK150761 Ez3D-i/E3Ewoosoft Co., Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK040171 Microderm, Model/Version 3.5Visiomed AG · 2004
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K070464ONDEMAND3DCybermed, Inc. · 2007 · cites it directly14descendants
- K113543ONDEMAND3DCybermed, Inc. · 2011 · 2 generations on9descendants
- K131616EZ3D-I, E3Ewoosoft Co., Ltd. · 2013 · 3 generations on4descendants
- K150761Ez3D-i/E3Ewoosoft Co., Ltd. · 2015 · 4 generations on3descendants
- K040171Microderm, Model/Version 3.5Visiomed AG · 2004 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| 0 (this device) | K032760 | Apax Pacs System | Tis, Inc. | 2003 | — |
| +1 | K070464 | ONDEMAND3D | Cybermed, Inc. | 2007 | — |
| +2 | K113543 | ONDEMAND3D | Cybermed, Inc. | 2011 | — |
| +3 | K131616 | EZ3D-I, E3 | Ewoosoft Co., Ltd. | 2013 | — |
| +4 | K150761 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2015 | — |
| +1 | K040171 | Microderm, Model/Version 3.5 | Visiomed AG | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K010259 | Mediface Pacs | 2001 |
What descends from it? (19)
See all 192 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?
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?
The Device is intended to be used by authorized staff to perform medical image management, communications, storage, archiving and review. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web. Typical users are trained professionals, including not limited to physicians, nurses, and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032760: Apax Pacs System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032760
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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