Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5900](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5900) → JAD — System, Therapeutic, X-Ray # JAD · System, Therapeutic, X-Ray _Radiology · 21 CFR 892.5900 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD ## Overview - **Product Code:** JAD - **Device Name:** System, Therapeutic, X-Ray - **Regulation:** [21 CFR 892.5900](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5900) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) ## 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](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K250692.md) | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | Dec 3, 2025 | SESE | | [K241174](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K241174.md) | 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](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K230611.md) | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | Xstrahl, Ltd. | Jul 13, 2023 | SESE | | [K213942](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K213942.md) | Esteya | Nucletron B.V. | Jan 11, 2022 | SESE | | [K190255](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K190255.md) | Sensus Healthcare TVM Balloon Applicator | Sensus Healthcare, Inc. | Feb 21, 2019 | SESE | | [K182641](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K182641.md) | Sensus IORT System | Sensus Healthcare, Inc. | Feb 21, 2019 | SESE | | [K173425](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K173425.md) | SRT-100+ | Sensus Healthcare, Inc. | Mar 23, 2018 | SESE | | [K172080](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K172080.md) | Photoelectric Therapy System | Xstrahl, Ltd. | Sep 29, 2017 | SESE | | [K162568](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K162568.md) | INTRABEAM 600 | Carl Zeiss Meditec, AG | Dec 15, 2016 | SESE | | [K153570](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K153570.md) | Axxent Electronic Brachytherapy System Model 110 XP 1200 | Icad, Inc. | Feb 25, 2016 | SESE | | [K150037](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K150037.md) | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | Sensus Healthcare | Oct 16, 2015 | SESE | | [K141343](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K141343.md) | AXXENT CERVICAL APPLICATOR | Icad, Inc. | Sep 5, 2014 | SESE | | [K132092](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K132092.md) | ESTEYA | Nucletron B.V. | Sep 26, 2013 | SESE | | [K131582](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K131582.md) | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM | Sensus Healthcare | Aug 28, 2013 | SESE | | [K130549](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K130549.md) | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR | Carl Zeiss Meditec, Inc. | Jun 26, 2013 | SESE | | [K123985](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K123985.md) | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 | Sensus Healthcare | May 14, 2013 | SESE | | [K122951](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K122951.md) | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | Icad, Inc. | Jan 17, 2013 | SESE | | [K121653](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K121653.md) | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS | Carl Zeiss Meditec, Inc. | Dec 27, 2012 | SESE | | [K110590](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K110590.md) | INTRABEAM NEEDLE APPLICATOR | Carl Zeiss Surgical GmbH | Apr 13, 2012 | SESE | | [K111299](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD/K111299.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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