# K042832: Sienet Cosmos (Version V15A)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Oct 28, 2004 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924178 (1993). 12 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033831: Sienet Cosmos, Siemens AG Medical Solutions (2003) Summary page 3.

## Most influential descendants
- K052461: Syngo Imaging Version V20A (2005), 2 descendants of its own
- K070755: Interworks (2007), 1 descendant of its own
- K141556: Avreo Interworks System (2014), 0 descendants of its own
- K070796: Chili Pacs (2007), 0 descendants of its own
- K060210: Mediport (2006), 0 descendants of its own

## Recalls of this device
- Apr 3, 2014 · Class II · Z-1622-2014: A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from
- Oct 3, 2006 · Not classified · Z-0069-2007: Potential loss of images. Images may not successfully be sent to the RAID system.
- Sep 22, 2005 · Not classified · Z-0092-06: reference lines appear above actual position

## Indications for use
The SIENET Cosmos is a Picture Archiving and Communication System (PACS) intended to enhance the complete imaging workflow, i.e. * Manipulating * Reading * Reporting * Viewing * 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. Therefore SIENET Cosmos supports the following generic imaging workflow: * Receive scheduled exams from IS at the SIENET Cosmos archiving component SDM * Provide relevant prior exams and reports (Structured Reports only) to the Modalities and Workplaces * Receive and store new exams from the Modalities at the SDM * 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 syngo® Viewing Studio is not intended for primary diagnosis.

Source page: https://510kreport.com/device/K042832
Methodology: https://510kreport.com/methodology