# K946320: R 302

- Pathway: 510(k) (Traditional)
- Applicant: Ralco S.R.L.
- Decided: May 11, 1995 after 134 days
- Product code: KPW (Device, Beam Limiting, X-Ray, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K080742: Verisuite 1.6, Verisuite-Particle 1.6 (2008), 5 descendants of its own
- K092653: Verisuite and Verisuite-Particle, Version 1.8 (2009), 3 descendants of its own
- K133914: Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle (2014), 2 descendants of its own
- K030487: R 72 (2003), 2 descendants of its own
- K181789: VeriSuite (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K946320
Methodology: https://510kreport.com/methodology