# K052537: Catella Diagnostic Workstation, Version 4.0

- Pathway: 510(k) (Abbreviated)
- Applicant: American Medical Sales, Inc.
- Decided: Nov 16, 2005 after 62 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913770 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033400: Seno Advantage, Ge Medical Systems W-400 (2003) Summary page 1.
- K033712: Modification to Sectra IDS5 Radiology Workstation - Version 10.1, Sectra-Imtec AB (2003) Summary page 1.
- K040376: Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package, Sectra-Imtec AB (2004) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K052537
Methodology: https://510kreport.com/methodology