# K964327: IPU RX-2

- Pathway: 510(k) (Traditional)
- Applicant: Medirex, Inc.
- Decided: Jan 17, 1997 after 79 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 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
- K040470: Tripter X-1 Compact (2004), 9 descendants of its own
- K041582: Modification to Tripter X-1 Compact Duet (2004), 8 descendants of its own
- K053640: Integra (2006), 6 descendants of its own
- K062147: Integra SL (2006), 3 descendants of its own
- K072538: Piezolith 3000 Triple-Focus Lithotripter (2008), 2 descendants of its own

Source page: https://510kreport.com/device/K964327
Methodology: https://510kreport.com/methodology