JAD · System, Therapeutic, X-Ray
Radiology · 21 CFR 892.5900 · Class 2
Overview
| Product Code | JAD |
|---|---|
| Device Name | System, Therapeutic, X-Ray |
| Regulation | 21 CFR 892.5900 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | Dec 3, 2025 | SESE |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | Carl Zeiss Meditec, AG | Jan 10, 2025 | SESE |
| K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | Xstrahl, Ltd. | Jul 13, 2023 | SESE |
| K213942 | Esteya | Nucletron B.V. | Jan 11, 2022 | SESE |
| K190255 | Sensus Healthcare TVM Balloon Applicator | Sensus Healthcare, Inc. | Feb 21, 2019 | SESE |
| K182641 | Sensus IORT System | Sensus Healthcare, Inc. | Feb 21, 2019 | SESE |
| K173425 | SRT-100+ | Sensus Healthcare, Inc. | Mar 23, 2018 | SESE |
| K172080 | Photoelectric Therapy System | Xstrahl, Ltd. | Sep 29, 2017 | SESE |
| K162568 | INTRABEAM 600 | Carl Zeiss Meditec, AG | Dec 15, 2016 | SESE |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | Icad, Inc. | Feb 25, 2016 | SESE |
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | Sensus Healthcare | Oct 16, 2015 | SESE |
| K141343 | AXXENT CERVICAL APPLICATOR | Icad, Inc. | Sep 5, 2014 | SESE |
| K132092 | ESTEYA | Nucletron B.V. | Sep 26, 2013 | SESE |
| K131582 | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM | Sensus Healthcare | Aug 28, 2013 | SESE |
| K130549 | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR | Carl Zeiss Meditec, Inc. | Jun 26, 2013 | SESE |
| K123985 | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 | Sensus Healthcare | May 14, 2013 | SESE |
| K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | Icad, Inc. | Jan 17, 2013 | SESE |
| K121653 | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS | Carl Zeiss Meditec, Inc. | Dec 27, 2012 | SESE |
| K110590 | INTRABEAM NEEDLE APPLICATOR | Carl Zeiss Surgical GmbH | Apr 13, 2012 | SESE |
| K111299 | AXXENT RADIATION SHIELD - RIGID | Xoft, an Icad Company | Jul 20, 2011 | SESE |
Top Applicants
- Xoft, Inc. — 5 clearances
- Carl Zeiss Surgical GmbH — 3 clearances
- Icad, Inc. — 3 clearances
- Sensus Healthcare — 3 clearances
- Sensus Healthcare, Inc. — 3 clearances
