# K955394: Sienet Teleradiology Product Line

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 21, 1996 after 89 days
- Product code: LMC (Camera, Multi Format, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033831: Sienet Cosmos (2003), 6 descendants of its own
- 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

## Recalls of this device
- Feb 18, 2015 · Class II · Z-1354-2015: Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived
- Jan 13, 2015 · Class II · Z-1027-2015: In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not 

Source page: https://510kreport.com/device/K955394
Methodology: https://510kreport.com/methodology