NZT · Dosimeter, Ionizing Radiation, Implanted
Radiology · 21 CFR 892.5050 · Class 2
Overview
| Product Code | NZT |
|---|---|
| Device Name | Dosimeter, Ionizing Radiation, Implanted |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| Implant | Yes |
Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Classification Rationale
Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250083 | PRO-DOSE System | Nu-Rise, SA | Oct 1, 2025 | SESE |
| K182395 | OARtrac System | Radialdyne, LLC | Mar 22, 2019 | SESE |
| K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | Radiadyne, LLC | Jun 1, 2017 | SESE |
| K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | Jun 16, 2015 | SESE |
| K141154 | OARTRAC SYSTEM | Radiadyne | Jul 22, 2014 | SESE |
| K083035 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | Nov 13, 2008 | SESE |
| K080004 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | Jan 23, 2008 | SESE |
Top Applicants
- Sicel Technologies, Inc. — 2 clearances
- Radiadyne, LLC — 2 clearances
- Radialdyne, LLC — 1 clearance
- Radiadyne — 1 clearance
- Nu-Rise, SA — 1 clearance
