510(k) K250083
- Device
- PRO-DOSE System
- Applicant
- Nu-Rise, SA
- 510(k) number
- K250083
- Product code
- NZT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-01
- Date received
- 2025-01-13
- Regulation
- 892.5050
- Classification name
- Dosimeter, Ionizing Radiation, Implanted
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Joana Melo
- Address
- Creative Science Park Via Do Conhecimento Ilhavo PT 3830-352 3830-352
Source Documents#
Other 510(k) Records For Product Code NZT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182395 | OARtrac System | Radialdyne, LLC | 2019-03-22 |
| K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | Radiadyne, LLC | 2017-06-01 |
| K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | 2015-06-16 |
| K141154 | OARTRAC SYSTEM | Radiadyne | 2014-07-22 |
| K083035 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | 2008-11-13 |
| K080004 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | 2008-01-23 |