510(k) · Cleared
ClearedStat Pacs Picture Archiving & Communication System (Pacs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Statrad, LLC · LLZ System, Image Processing, Radiological
Cleared on Sep 15, 2009 as substantially equivalent to K090649 (Virtual Radiologic Corporation, 2009) and 2 other predicates after a 62-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Sep 15, 2009
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K945188 (1995). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 5 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 4 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 3 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 2 generations backK072205 Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
- 1 generation backK082269 Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc. · 2008
- This deviceK092134 Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC · 2009
- Descendant · cites it directly · 0 of its ownK171130 Nucleus Image Management SystemNucleushealth, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K171130Nucleus Image Management SystemNucleushealth, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −5 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −4 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −3 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −2 | K072205 | Visage Pacs/CS, Release Version 5.0 | Mercury Computer Systems, Inc. | 2007 | — |
| −1 | K082269 | Visage Pacs, Version 6.0/CS 3.1 | Visage Imaging, Inc. | 2008 | — |
| 0 (this device) | K092134 | Stat Pacs Picture Archiving & Communication System (Pacs) | Statrad, LLC | 2009 | — |
| +1 | K171130 | Nucleus Image Management System | Nucleushealth, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K090649 | Vrad Picture Archiving and Communications System SoftwareSummary page 1…Medical Imaging Processing/Teleradiology System Proprietary Name: StatPacsTM Predicate device(s): Virtual Radiologic Corporation vRad PACS K090649 11995 Singletree Lane Minneapolis, MN 55344… | 2009 |
| * | K062490 | Visage Pacs/CS, Release Version 4.1Summary page 1…polis, MN 55344 Mercury Computer Systems Inc. VISAGE PACS/CS 199 Rivemeck Rd. K062490 Chelmsford, MA 01824-2820 VISAGE IMAGING, INC VIS… | 2006 |
| * | K082269 | Visage Pacs, Version 6.0/CS 3.1Summary page 1…, MA 01824-2820 VISAGE IMAGING, INC VISAGE PACS/CS 1815 ASTON AVENUE, SUITE 107 K082269 CARLSBAD, CALIFORNIA, 92008 Description/Intended use: The StatPacsTM is a software based PACS pr… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171130 | Nucleus Image Management System | 2017 | 0 |
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 14 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K171130 (Nucleushealth, LLC, 2017) 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. 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 StatPacsTM is a software based PACS product intended to be used by radiologists, technologists and clinicians, to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospital and remote site use. The StatPacsTM software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis by way of industry standard networked gateways including VPNs, and LAN/WAN through DICOM…
Read the full statement (135 words)
The StatPacsTM is a software based PACS product intended to be used by radiologists, technologists and clinicians, to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospital and remote site use. The StatPacsTM software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis by way of industry standard networked gateways including VPNs, and LAN/WAN through DICOM allowing StatPacsTM to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatViewTM with the Exam ManagerTM application, is a primary user interface for processing of medical images for primary image diagnosis. Image compression and encryption adhere to standard industry protocol. StatPacsTM, is not to be used for mammography imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092134: Stat Pacs Picture Archiving & Communication System (Pacs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092134
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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