# K014058: Entegra PE Personal Digital Assistant

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems
- Decided: Dec 21, 2001 after 11 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: 1 generation back to K000395 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000395: Einstein Processing and Review Workstation, Ge Medical Systems F.I. Haifa (2000) Summary page 1.

## Indications for use
eNTEGRA PE is designed to display, process, archive, and communicate data raquired and stored by Emission Tomography cameras and Nuclear Medicine/PET workstations. It is intended that use of the device be limited to review of studies, tagging images for detailed reading, determining whether the correct images were captured, and similar uses. The limited image size availble on eNTEGRA PE has not been fully demonstrated to be suitable for diagnostic use, and it is not intended to be used for direct diagnosis.

Source page: https://510kreport.com/device/K014058
Methodology: https://510kreport.com/methodology