510(k) · Cleared
ClearedIntelePACS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelerad Medical Systems Incorporated · LLZ System, Image Processing, Radiological
Cleared on May 27, 2015 as substantially equivalent to K083520 (Intelerad Medical Systems Incorporated, 2009) after a 69-day review. Its family tree reaches back 1 generation to 2009. 2 later devices descend from it.
- Decided
- May 27, 2015
- Review
- 69 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083520 (2009). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK083520 Intelepacs, Model Version 3.X.XIntelerad Medical Systems Incorporated · 2009 · Recalled
- This deviceK150707 IntelePACSIntelerad Medical Systems Incorporated · 2015
- Descendant · cites it directly · 0 of its ownK192176 IntelePACSIntelerad Medical Systems Incorporated · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK162141 Restore PACSXian Wingspan Electronic Technology Co., Ltd. · 2016
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 |
|---|---|---|---|---|---|
| −1 | K083520 | Intelepacs, Model Version 3.X.X | Intelerad Medical Systems Incorporated | 2009 | 1 |
| 0 (this device) | K150707 | IntelePACS | Intelerad Medical Systems Incorporated | 2015 | — |
| +1 | K192176 | IntelePACS | Intelerad Medical Systems Incorporated | 2020 | 3 |
| +1 | K162141 | Restore PACS | Xian Wingspan Electronic Technology Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K083520 | Intelepacs, Model Version 3.X.XSummary page 4…) IntelePACS™ system is substantially equivalent to: Device Classification Name system, image processing, radiological22 510(k) Number K083520 Device Name INTELEPACS, MODEL VERSION 3.X.X Original Applicant INTELERAD MEDICAL SYSTEMS… | 2009 |
| † | K142337 | Blackford Analysis Registration Product Family | 2015 |
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?
- Its one ancestor has a recall.
- Of its descendants, K192176 (Intelerad Medical Systems Incorporated, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
IntelePACS™ 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…
Read the full statement (121 words)
IntelePACS™ 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).
Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and cleared by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
Contraindications: Lossy compressed images and digitized film screen images must not be reviewed for primary image interpretations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150707: IntelePACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150707
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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