510(k) · Cleared
ClearedCatella Diagnostic Workstation, Version 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Sales, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 16, 2005 as substantially equivalent to K033400 (Ge Medical Systems W-400, 2003) and 2 other predicates after a 62-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Nov 16, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K913770 (1991). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 2 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 1 generation backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- This deviceK052537 Catella Diagnostic Workstation, Version 4.0American Medical Sales, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −2 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −1 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| 0 (this device) | K052537 | Catella Diagnostic Workstation, Version 4.0 | American Medical Sales, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K033400 | Seno AdvantageSummary page 1…listed below: Model: Seno Advantage Manufacturer: GE Medical Systems 5 10 (k) Number: K033400 Model: Sectra IDS5 Radiology Workstation Manufacturer: Sectra-Imtec A… | 2003 |
| * | K033712 | Modification to Sectra IDS5 Radiology Workstation - Version 10.1Summary page 1…Model: Sectra IDS5 Radiology Workstation Manufacturer: Sectra-Imtec Ab 5 10 (k) Number: K0337 12, K040376 Abbreviated 510(k) PreMarket Notification 1 American Medical Sales, Inc… | 2003 |
| * | K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageSummary page 1…Model: Sectra IDS5 Radiology Workstation Manufacturer: Sectra-Imtec Ab 5 10 (k) Number: K0337 12, K040376 Abbreviated 510(k) PreMarket Notification 1 American Medical Sales, Inc. Catella… | 2004 |
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 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 8 other devices also cite its predicate K033400.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Catella Diagnostic Workstation, Version 4.0, is a medical image and information management system that allows easy viewing, selection, processing, printing, telecommunications, and media interchange of multi-modality medical images from a variety of diagnostic imaging systems. The Catella PACS interfaces to various storage and printing devices using DICOM or similar interface standards. The system is available for diagnostic and non-diagnostic…
Read the full statement (224 words)
The Catella Diagnostic Workstation, Version 4.0, is a medical image and information management system that allows easy viewing, selection, processing, printing, telecommunications, and media interchange of multi-modality medical images from a variety of diagnostic imaging systems. The Catella PACS interfaces to various storage and printing devices using DICOM or similar interface standards. The system is available for diagnostic and non-diagnostic workstations, including workstations designed as web-based, remote viewers or CD-viewer workstations. The software may be installed as a PC-based stand alone system, a software application, a web-based or SDK format, and is designed to be integrated with various DICOM compliant OEM systems.
The Catella PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MR, CT, DR, CR, X-ray, Angiography, Ultrasound, or digitizers. The Catella Diagnostic Workstation, Version 4.0 performs other user-defined post-processing functions, such as multi-planar reformatting of images. The Catella PACS can display processed data from certain FDA-cleared third party image processing systems that create DICOM output. With proper links, the Catella Workstation also can invoke FDA-cleared third party image processing systems for advanced image processing, such as 3D display. It can also access RIS and HIS systems and can be used to review patient, information.
The Catella Diagnostic Workstation, Version 4.0, is not intended for use for primary diagnostic interpretation of mammographic images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052537: Catella Diagnostic Workstation, Version 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052537
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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