# K071492: Firstview

- Pathway: 510(k) (Traditional)
- Applicant: Riverain Medical Group,Llc
- Decided: Aug 28, 2007 after 90 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: 5 generations back to K913770 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051743: R2 Breast Imaging Workstation, R2 Technology, Inc. (2005)
- K043415: Centricity Pacs System, Ge Medical Systems Information Technologies (2005) Summary page 1.
- K981217: Platinum Reading, Review & Analysis Workstation, GE Medical Systems (1998) Summary page 1.

## Indications for use
The FirstViewTM is indicated for displaying and manipulating chest x-ray images. It acts as an interface with the CAD component, if installed or available at the clinical site, and provides display of information contained within the DICOM header of the images. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians.

Source page: https://510kreport.com/device/K071492
Methodology: https://510kreport.com/methodology