510(k) · Cleared
ClearedIntelepacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelerad Medical Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 16, 2003 as substantially equivalent to K023460 (Medical Standard Co., Ltd., 2003) after a 62-day review. Its family tree reaches back 3 generations to 2001. 7 later devices descend from it.
- Decided
- Oct 16, 2003
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010259 (2001). 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 2 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 1 generation backK023460 PacsplusMedical Standard Co., Ltd. · 2003
- This deviceK032533 IntelepacsIntelerad Medical Systems, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK070080 IntelepacsIntelerad Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 4 of its ownK110332 Clearcanvas Ris / PacsClearcanvas, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK191530 StoneCheckerImaging Biometrics, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK213660 RadAllyImaging Wave, LLC · 2023
- Descendant · 4 generations on · 0 of its ownK202084 DeepLook PRECISEDeeplook, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K070080IntelepacsIntelerad Medical Systems, Inc. · 2007 · cites it directly5descendants
- K110332Clearcanvas Ris / PacsClearcanvas, Inc. · 2011 · 2 generations on4descendants
- K191530StoneCheckerImaging Biometrics, LLC · 2019 · 3 generations on1descendant
- K213660RadAllyImaging Wave, LLC · 2023 · 3 generations on0descendants
- K202084DeepLook PRECISEDeeplook, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −2 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −1 | K023460 | Pacsplus | Medical Standard Co., Ltd. | 2003 | — |
| 0 (this device) | K032533 | Intelepacs | Intelerad Medical Systems, Inc. | 2003 | — |
| +1 | K070080 | Intelepacs | Intelerad Medical Systems, Inc. | 2007 | 2 |
| +2 | K110332 | Clearcanvas Ris / Pacs | Clearcanvas, Inc. | 2011 | 1 |
| +3 | K191530 | StoneChecker | Imaging Biometrics, LLC | 2019 | — |
| +3 | K213660 | RadAlly | Imaging Wave, LLC | 2023 | — |
| +4 | K202084 | DeepLook PRECISE | Deeplook, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K023460 | Pacsplus | 2003 |
What descends from it? (7)
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 2 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K070080 (Intelerad Medical Systems, Inc., 2007) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K023460.
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?
IntelePACS is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032533: Intelepacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032533
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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