JAD — System, Therapeutic, X-Ray Class II
FDA product code JAD covers "System, Therapeutic, X-Ray", a Class II medical device regulated under 21 CFR 892.5900. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JAD
- Device Class
- Class II
- Regulation Number
- 892.5900
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250692 | voxel ray solutions | GentleBeam (GB1000) | December 3, 2025 |
| K241174 | carl zeiss meditec | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spheric | January 10, 2025 |
| K230611 | xstrahl | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | July 13, 2023 |
| K213942 | nucletron | Esteya | January 11, 2022 |
| K182641 | sensus healthcare | Sensus IORT System | February 21, 2019 |
| K190255 | sensus healthcare | Sensus Healthcare TVM Balloon Applicator | February 21, 2019 |
| K173425 | sensus healthcare | SRT-100+ | March 23, 2018 |
| K172080 | xstrahl | Photoelectric Therapy System | September 29, 2017 |
| K162568 | carl zeiss meditec | INTRABEAM 600 | December 15, 2016 |
| K153570 | icad | Axxent Electronic Brachytherapy System Model 110 XP 1200 | February 25, 2016 |
| K150037 | sensus healthcare | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Ima | October 16, 2015 |
| K141343 | icad | AXXENT CERVICAL APPLICATOR | September 5, 2014 |
| K132092 | nucletron | ESTEYA | September 26, 2013 |
| K131582 | sensus healthcare | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM | August 28, 2013 |
| K130549 | carl zeiss meditec | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR | June 26, 2013 |
| K123985 | sensus healthcare | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 | May 14, 2013 |
| K122951 | icad | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | January 17, 2013 |
| K121653 | carl zeiss meditec | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS | December 27, 2012 |
| K110590 | carl zeiss surgical | INTRABEAM NEEDLE APPLICATOR | April 13, 2012 |
| K111299 | xoft, an icad | AXXENT RADIATION SHIELD - RIGID | July 20, 2011 |