# Isoray Medical, Inc.

- Location (FDA's records): Richland, WA
- FDA decisions: 5 (2009–2020): 5 510(k) clearances
- Product codes: KXK (5)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Isoray, Inc.: 2 (https://510kreport.com/company/isoray)
- Proxima Therapeutics, Inc.: 1 (https://510kreport.com/company/proxima-therapeutics)

## Firms that cite its devices most
- Gt Medical Technologies: 1 (https://510kreport.com/company/gt-medical-technologies)
- Isoray, Inc.: 1 (https://510kreport.com/company/isoray)

## Its most-cited devices
- K111931: Gliasite RTS (2011), cited by 1
- K180515: GammaTile (2018), cited by 1
- K092136: Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 (2009), cited by 1
- K092458: Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18 Guage Needles, Model PL-2 (2009), cited by 1

## Recent decisions
- K202267: Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles (Dec 31, 2020)
- K180515: GammaTile (Jul 6, 2018)
- K111931: Gliasite RTS (Aug 5, 2011)
- K092458: Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18 Guage Needles, Model PL-2 (Aug 28, 2009)
- K092136: Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 (Aug 7, 2009)

Source page: https://510kreport.com/company/isoray-medical