# K033831: Sienet Cosmos

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Dec 19, 2003 after 9 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924178 (1993). 11 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K920309: Sienet Diagnostic Reporting Console, Siemens Gammasonics, Inc. (1992) Summary page 3.
- K935694: Sienet Diagnostic Reporting Console VA02 Upgrade, Siemens Medical Solutions USA, Inc. (1994) Summary page 3.
- K955394: Sienet Teleradiology Product Line, Siemens Medical Solutions USA, Inc. (1996) Summary page 3.
- K010938: Syngo Multimodality Workstation, Siemens Medical Solutions USA, Inc. (2001) Summary page 3.
- K973131: Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway), Siemens Medical Solutions USA, Inc. (1997) Summary page 3.
- K920310: Sienet Archive Server, Isa I, Isa II Storage Serve, Siemens Gammasonics, Inc. (1992) Summary page 3.

## Most influential descendants
- K042832: Sienet Cosmos (Version V15A) (2004), 5 descendants of its own
- 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

## 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

## 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). The workstation deployment syngo Viewing Studio is not intended for primary diagnosis.

Source page: https://510kreport.com/device/K033831
Methodology: https://510kreport.com/methodology