510(k) · Cleared
ClearedSmartpacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Electronic Data Processing Corporation · LLZ System, Image Processing, Radiological
Cleared on Oct 11, 2002 as substantially equivalent to K002936 (Sectra-Imtec AB, 2000) after a 58-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Oct 11, 2002
- Review
- 58 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002936 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK002936 Modification to IDS5 Image Display SystemSectra-Imtec AB · 2000
- This deviceK022710 SmartpacsTaiwan Electronic Data Processing Corporation · 2002
- Descendant · cites it directly · 2 of its ownK083182 Datacom DC PacsDatacom Technology Corp. · 2009
- Descendant · cites it directly · 1 of its ownK082808 Imagesvr PacsJaguar Technology Limited · 2009
- Descendant · 2 generations on · 0 of its ownK152034 FS-PacsEc-Web Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK092125 Presidio PacsReaonix Security, LLC · 2009
- Descendant · cites it directly · 0 of its ownK042507 UbipacsIcm Co., Ltd. · 2004
Most influential descendants
Showing 5 of 5 · See all- K083182Datacom DC PacsDatacom Technology Corp. · 2009 · cites it directly2descendants
- K082808Imagesvr PacsJaguar Technology Limited · 2009 · cites it directly1descendant
- K152034FS-PacsEc-Web Co., Ltd. · 2016 · 2 generations on0descendants
- K092125Presidio PacsReaonix Security, LLC · 2009 · 2 generations on0descendants
- K042507UbipacsIcm Co., Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002936 | Modification to IDS5 Image Display System | Sectra-Imtec AB | 2000 | — |
| 0 (this device) | K022710 | Smartpacs | Taiwan Electronic Data Processing Corporation | 2002 | — |
| +1 | K083182 | Datacom DC Pacs | Datacom Technology Corp. | 2009 | — |
| +1 | K082808 | Imagesvr Pacs | Jaguar Technology Limited | 2009 | — |
| +2 | K152034 | FS-Pacs | Ec-Web Co., Ltd. | 2016 | — |
| +2 | K092125 | Presidio Pacs | Reaonix Security, LLC | 2009 | — |
| +1 | K042507 | Ubipacs | Icm Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 3 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K002936 | Modification to IDS5 Image Display System | 2000 |
What descends from it? (5)
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?
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 SmartPACSTMdevice is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstations, image storage and printing devices using DICOM or similar standards.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022710: Smartpacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022710
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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