# K092363: Softview, Model 2.01

- Pathway: 510(k) (Traditional)
- Applicant: Riverain Medical Group
- Decided: Mar 18, 2010 after 225 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 K862120 (1986). 6 ancestors in all.
34 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013481: Dual Energy and Tissue Equalization Software Option, GE Medical Systems (2001)

## Most influential descendants
- K123526: Clearread +Confirm (2012), 25 descendants of its own
- K162278: Digital Diagnostic Mobile X-ray System (2016), 23 descendants of its own
- K171119: GM85 (2017), 22 descendants of its own
- K173828: GU60A & GU60A-65 (2018), 19 descendants of its own
- K180543: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (2018), 18 descendants of its own

## Indications for use
SoftView is intended to generate an enhanced, secondary digital radiographic image of the chest. The enhanced AP or PA image of the chest provides improved visibility of the lung parenchyma through bone suppression and tissue equalization, and may facilitate discerning the presence or absence of nodules. The SoftView image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians on patients with risk of having lung nodules and is not intended to be used on pediatric patients.

Source page: https://510kreport.com/device/K092363
Methodology: https://510kreport.com/methodology