# K003607: Onyx-Rad Telemedicine Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Viztek, Inc.
- Decided: Feb 15, 2001 after 85 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K103554: Metron-CP/MD (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K003607
Methodology: https://510kreport.com/methodology