# K031248: Consultiva Report Station, Model RS-1

- Pathway: 510(k) (Traditional)
- Applicant: Miramedica, Inc.
- Decided: Jun 20, 2003 after 63 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: 4 generations back to K913475 (1991). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013922: Coronis 3MP Medicl Flat Panel Display System, Barco N.V. (2002)
- K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho, Agfa Corp. (2002)
- K023003: Imagechecker-CT Workstation, R2 Technology, Inc. (2002)

## Most influential descendants
- K050667: R2 Family of Image Display Units with R2 Uniform Display Software (2005), 0 descendants of its own

## Indications for use
The ConsultivaTMReport Station is a software application intended to be used to display low resolution, non-diagnostic medical images with annotations such as regions-of-interest or CAD marks.

Source page: https://510kreport.com/device/K031248
Methodology: https://510kreport.com/methodology