# K111776: Deltaview Model 2.1

- Pathway: 510(k) (Traditional)
- Applicant: Riverain Medical Group,Llc
- Decided: Dec 28, 2011 after 188 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: 6 generations back to K862120 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092363: Softview, Model 2.01, Riverain Medical Group (2010) Summary page 1.

## Indications for use
DeltaView is intended to generate a secondary residual image based on a current and prior chest x-ray image of the same patient, resulting in improved detection of lung nodules that have changed between the two examinations. The DeltaView image provides adjunctive information and is not a substitute for the original PAIAP image. This device is intended to be used by trained professionals, such as physicians and radiologists, on patients with risk of having lung nodules, and is not intended to be used on pediatric patients.

Source page: https://510kreport.com/device/K111776
Methodology: https://510kreport.com/methodology