# Medirex, Inc.

- Location (FDA's records): Wellesley Hills, MA
- FDA decisions: 4 (1996–1997): 3 510(k) clearances and 1 original PMA approval
- Product codes: OXO (2), LLZ (1), LNS (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Direx Systems Corp.: 4 (https://510kreport.com/company/direx-systems)

## Its most-cited devices
- P920034: Tripter-X1 Nova (1996), cited by 2
- K965013: Digiscope RX-2 (9 Option) (1997), cited by 1
- K964327: IPU RX-2 (1997), cited by 1

## Recent decisions
- K965013: Digiscope RX-2 (9 Option) (Jan 17, 1997)
- K964327: IPU RX-2 (Jan 17, 1997)
- P920034: Tripter-X1 Nova (Sep 20, 1996)
- K960198: Digiscope RX-2 (Mar 12, 1996)

Source page: https://510kreport.com/company/medirex