# Radiadyne

- Location (FDA's records): Houston, TX
- FDA decisions: 5 (2009–2017): 4 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Radiadyne (3); Radiadyne, LLC (2)
- Product codes: NZT (3), JAQ (1), PCT (1)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 9 (4 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
- Mick Radio-Nuclear Instruments, Inc.: 1 (https://510kreport.com/company/mick-radio-nuclear-instruments)
- Sterinc: 1 (https://510kreport.com/company/sterinc)
- Sicel Technologies, Inc.: 1 (https://510kreport.com/company/sicel-technologies)

## Firms that cite its devices most
- Edge Medical, LLC: 1 (https://510kreport.com/company/edge-medical)
- Dxtx Medical, Inc.: 1 (https://510kreport.com/company/dxtx-medical)
- Radiadyne, LLC (Specification Developer): 1 (https://510kreport.com/company/radiadyne-specification-developer)
- Myriad Medical, LLC: 1 (https://510kreport.com/company/myriad-medical)
- Radialdyne, LLC: 1 (https://510kreport.com/company/radialdyne)

## Its most-cited devices
- DEN130036: Prostate Immobilizer Rectal Balloon (2014), cited by 4
- K141154: Oartrac System (2014), cited by 2
- K162954: OARtrac System with Patient Specific Reusable Universal PSD Sensors (2017), cited by 1
- K150719: OARtrac System with Skin Sensors (2015), cited by 1
- K092534: Alatus Vaginal Balloon Packing System (2009), cited by 1

## Recent decisions
- K162954: OARtrac System with Patient Specific Reusable Universal PSD Sensors (Jun 1, 2017)
- K150719: OARtrac System with Skin Sensors (Jun 16, 2015)
- K141154: Oartrac System (Jul 22, 2014)
- DEN130036: Prostate Immobilizer Rectal Balloon (Jan 28, 2014)
- K092534: Alatus Vaginal Balloon Packing System (Dec 7, 2009)

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