510(k) · Cleared
Recalled · 2008Intelepacs
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 Jan 24, 2007 as substantially equivalent to K032533 (Intelerad Medical Systems, Inc., 2003) and 2 other predicates after a 15-day review. Its family tree reaches back 4 generations to 2001. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 24, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010259 (2001). 7 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 3 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 2 generations backK023460 PacsplusMedical Standard Co., Ltd. · 2003
- 1 generation backK032533 IntelepacsIntelerad Medical Systems, Inc. · 2003
- This deviceK070080 IntelepacsIntelerad Medical Systems, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK110332 Clearcanvas Ris / PacsClearcanvas, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK191530 StoneCheckerImaging Biometrics, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK213660 RadAllyImaging Wave, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK202084 DeepLook PRECISEDeeplook, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK181460 OnePacs SystemOnepacs, LLC · 2018
Most influential descendants
Showing 5 of 5 · See all- K110332Clearcanvas Ris / PacsClearcanvas, Inc. · 2011 · cites it directly4descendants
- K191530StoneCheckerImaging Biometrics, LLC · 2019 · 2 generations on1descendant
- K213660RadAllyImaging Wave, LLC · 2023 · 2 generations on0descendants
- K202084DeepLook PRECISEDeeplook, Inc. · 2021 · 3 generations on0descendants
- K181460OnePacs SystemOnepacs, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −3 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −2 | K023460 | Pacsplus | Medical Standard Co., Ltd. | 2003 | — |
| −1 | K032533 | Intelepacs | Intelerad Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K070080 | Intelepacs | Intelerad Medical Systems, Inc. | 2007 | — |
| +1 | K110332 | Clearcanvas Ris / Pacs | Clearcanvas, Inc. | 2011 | 1 |
| +2 | K191530 | StoneChecker | Imaging Biometrics, LLC | 2019 | — |
| +2 | K213660 | RadAlly | Imaging Wave, LLC | 2023 | — |
| +3 | K202084 | DeepLook PRECISE | Deeplook, Inc. | 2021 | — |
| +2 | K181460 | OnePacs System | Onepacs, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K032533 | IntelepacsSummary page 1…21 CFR 807. 92(a)(3) Device Classification Name SYSTEM, IMAGE PROCESSING, RADIOLOGICAL [Regulation Number 892.2050 510(k) Number K032533 [Device Name kIntelePACS ~Applicant elerad Medical Systems Incorporated Product… | 2003 |
| * | K023460 | PacsplusSummary page 2…gy Device Classification Name SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Regulation Number 1892.2050 [510(k) Number K023460 Device Name PACSPLUS ~Appl~icant MEDICAL STANDARD CO., LTD. Product Code… | 2003 |
| * | K061672 | Synapse Mip/MPR Image Visualization Software ObliquusSummary page 2…Radiology DeviceClassificationName IISystem, Image, Processing, Radiological Regulation Number 892.2050 510(k)Number IIK061672 Devicyname3MIP/MPR Image Visualization Software Applicant… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110332 | Clearcanvas Ris / Pacs | 2011 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 27, 2008 | Not classified | Z-1885-2009 | Software design | Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective. |
| Oct 27, 2008 | Not classified | Z-1884-2009 | Software design | Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K110332 (Clearcanvas, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K032533.
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?
IntelePACSTM is a device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and 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.…
Read the full statement (129 words)
IntelePACSTM is a device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and 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. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR).
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.
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/K070080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070080: Intelepacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070080
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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