# K000395: Einstein Processing and Review Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems F.I. Haifa
- Decided: May 3, 2000 after 86 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
No predicates in its family tree.
207 later devices descend from it; 3 cite it directly.
0 of 208 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
- K024137: Jupiter Processing and Review Workstation (2003), 193 descendants of its own
- K051673: Xeleris 2 Processing and Review Workstation (2005), 192 descendants of its own
- K093982: Xeleris 3 Processing and Review Workstation (2010), 134 descendants of its own
- K130884: Xeleris 3.1 Processing and Review Workstation (2013), 77 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own

Source page: https://510kreport.com/device/K000395
Methodology: https://510kreport.com/methodology