# K070394: Cerner Provision Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Cerner Corp.
- Decided: Mar 27, 2007 after 46 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The CernerProVision Workstation is a software application intended for the rendering, visualization and manipulating of medical images to support the image display needs of clinicians, diagnosticians and technologists. Application capabilities enable primary diagnostic review, interpretation and distribution viewing for physician review. The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA

Source page: https://510kreport.com/device/K070394
Methodology: https://510kreport.com/methodology
