510(k) · Cleared
ClearedChili Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chili GmbH · LLZ System, Image Processing, Radiological
Cleared on Apr 6, 2007 as substantially equivalent to K052461 (Siemens AG Medical Solutions, 2005) after a 14-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Apr 6, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924178 (1993). 19 ancestors in all, the oldest K920309 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
- 5 generations backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
- 4 generations backK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
- 3 generations backK033831 Sienet CosmosSiemens AG Medical Solutions · 2003 · Recalled
- 2 generations backK042832 Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004 · Recalled
- 1 generation backK052461 Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · Recalled
- This deviceK070796 Chili PacsChili GmbH · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924178 | Medvision (TM) Imaging Software | Evergreen Technologies, Inc. | 1993 | — |
| −5 | K970064 | Amicas Web/Intranet Image Server | Autocyt Group, Inc. | 1997 | — |
| −4 | K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway) | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −3 | K033831 | Sienet Cosmos | Siemens AG Medical Solutions | 2003 | 1 |
| −2 | K042832 | Sienet Cosmos (Version V15A) | Siemens AG Medical Solutions | 2004 | 3 |
| −1 | K052461 | Syngo Imaging Version V20A | Siemens AG Medical Solutions | 2005 | 3 |
| 0 (this device) | K070796 | Chili Pacs | Chili GmbH | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 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 21.6 · 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 |
|---|---|---|---|
| * | K052461 | Syngo Imaging Version V20ASummary page 1…Class II Classification Code: 21 CFR §892,2050 Classification Panel: Radiology Predicate Device: syngo Imaging Version V20A (K052461) Reason for the 510 (k): New device 3.3 Device Description and Intended Use This premarket notification covers CHILI… | 2005 |
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 14 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K052461.
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?
The CHILI PACS is a Picture Archiving and Communication System (PACS) intended to enhance the complete imaging workflow, i.e. * Displaying * Processing * Reading * Reporting * Communicating / distributing * Storing / archiving of radiological softcopy images and * Storing / archiving of structured (DICOM) reports, The system is a 'software only" solution and is intended to assist the physician in diagnosis or treatment planning (excluding screening and…
Read the full statement (180 words)
The CHILI PACS is a Picture Archiving and Communication System (PACS) intended to
enhance the complete imaging workflow, i.e.
* Displaying
* Processing
* Reading
* Reporting
* Communicating / distributing
* Storing / archiving of radiological softcopy images and
* Storing / archiving of structured (DICOM) reports,
The system is a 'software only" solution and is intended to assist the physician in diagnosis or
treatment planning (excluding screening and primary diagnosis of mammography images).
Therefore CHILI PACS supports the following generic imaging workflow:
* Receive scheduled exams from ISat the CHILI PACS archiving component CHILI
Server
* Provide relevant prior exams and reports (Structured Reports only) to the Modalities
and Workplaces
* Receive and store new exams from the Modalities at the CHILI Server
* Prepare images for reading
* Report new images, if required by comparing them with prior exams and reports
* Demonstrate exams at Radiological Demos
* View exams and reports at Workplaces outside Radiology (e.g. Surgery, Intensive
Case Unit, wards, external referring physicians).
Note: The workstation deployment CHILI 3D-Plugln is not intended for primary diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070796 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070796: Chili Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070796
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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