# K063337: Opal-Rad

- Pathway: 510(k) (Traditional)
- Applicant: Viztek, Inc.
- Decided: Dec 12, 2006 after 36 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: 3 generations back to K010259 (2001). 3 ancestors in all.
45 later devices descend from it; 5 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032176: Rattan Imacs by Rattan Information Corporation, Rattan Information Corporation (2003) Summary page 1.

## Most influential descendants
- K102123: Vizion DR (2011), 36 descendants of its own
- K112661: Vizion DR (2011), 34 descendants of its own
- K123644: Vizion + DR (2013), 33 descendants of its own
- K152279: ViZion DR + Wireless (2015), 27 descendants of its own
- K161730: Wireless Digital Flat Panel Detector (2016), 24 descendants of its own

## Indications for use
Opal-RADTM is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used. Typical users of this system are trained professionals, nurses, and technicians.

Source page: https://510kreport.com/device/K063337
Methodology: https://510kreport.com/methodology