# K080325: IGROK

- Pathway: 510(k) (Traditional)
- Applicant: Igrok, LLC
- Decided: Apr 8, 2008 after 62 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: 9 generations back to K954874 (1996). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070248: Velocityais, Velocity Medical Solutions, LLC (2007) Summary page 1.

## Indications for use
IGROK is a hardware/software system that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. Certain registration functions and analyses are only applicable in pelvic, head and neck areas. IGROK is not intended for mammography diagnosis.

Source page: https://510kreport.com/device/K080325
Methodology: https://510kreport.com/methodology