510(k) · Cleared
ClearedPresidio Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reaonix Security, LLC · LLZ System, Image Processing, Radiological
Cleared on Dec 10, 2009 as substantially equivalent to K082808 (Jaguar Technology Limited, 2009) and 1 other predicate after a 148-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 10, 2009
- Review
- 148 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002936 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK002936 Modification to IDS5 Image Display SystemSectra-Imtec AB · 2000
- 2 generations backK022710 SmartpacsTaiwan Electronic Data Processing Corporation · 2002
- 1 generation backK082808 Imagesvr PacsJaguar Technology Limited · 2009
- This deviceK092125 Presidio PacsReaonix Security, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002936 | Modification to IDS5 Image Display System | Sectra-Imtec AB | 2000 | — |
| −2 | K022710 | Smartpacs | Taiwan Electronic Data Processing Corporation | 2002 | — |
| −1 | K082808 | Imagesvr Pacs | Jaguar Technology Limited | 2009 | — |
| 0 (this device) | K092125 | Presidio Pacs | Reaonix Security, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (2)
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 |
|---|---|---|---|
| * | K082808 | Imagesvr PacsSummary page 1…I - 892.2050 Panel Code Device: Radiology Product Cede: LIZ Predicate Device Information: Device Name: IMAGESVR PACS Manufacturer: JAGUAR TECHNOLOGY LIMITED Reference: K082808 Device Name: DATACOM DC PACS Manufacturer: DATACOM TECHNOLOGY CORP. Reference: K(083182 Device Description: The Presidio PACS i… | 2009 |
| * | K083182 | Datacom DC PacsSummary page 1…: Device Name: IMAGESVR PACS Manufacturer: JAGUAR TECHNOLOGY LIMITED Reference: K082808 Device Name: DATACOM DC PACS Manufacturer: DATACOM TECHNOLOGY CORP. Reference: K(083182 Device Description: The Presidio PACS include the following major components: Workstation, Enterprise and RIS. The Presidio PAC… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The Presidio PACS software 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 workstation, 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. To support the…
Read the full statement (149 words)
The Presidio PACS software 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 workstation, 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.
To support the diagnostic interpretation of mammography studies, Presidio PACS will display the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092125: Presidio Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092125
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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