Home › Device types › JAD
System, Therapeutic, X-Ray
FDA product code JAD · Class 2 · Radiology
147
Registered devices
78
Adverse events
12
Recalls
53
510(k) clearances
Devices with this code
INTRABEAM SMART Spherical Applicator (35mm) — Carl Zeiss Meditec AGEsteya — Nucletron B.V.Surface Applicator Cone, 35 mm — Icad, Inc.Action® — ACTION PRODUCTS, INC.Action® — ACTION PRODUCTS, INC.Xstrahl 300 X-Ray System Ceiling — XSTRAHL LIMITEDVaginal Applicator, 20mm — Icad, Inc.INTRABEAM® Surface Applicator Set 4.0 cm — Carl Zeiss Meditec AGINTRABEAM® Spherical Applicator 3.0 cm — Carl Zeiss Meditec AGAction® — ACTION PRODUCTS, INC.Xstrahl 200 X-Ray System - Ceiling — XSTRAHL LIMITEDINTRABEAM® Spherical Applicator 1.5 cm — Carl Zeiss Meditec AGINTRABEAM SMART Spherical Applicator — Carl Zeiss Meditec AGBalloon Applicator Kit — Icad, Inc.Balloon Applicator — Icad, Inc.Surface Applicator Cone, 20 mm — Icad, Inc.Esteya — Nucletron B.V.Action® — ACTION PRODUCTS, INC.Xstrahl 100 X-Ray System — XSTRAHL LIMITEDAction® — ACTION PRODUCTS, INC.INTRABEAM® Spherical Applicator 4.5 cm — Carl Zeiss Meditec AGINTRABEAM® Spherical Applicator 2.0 cm — Carl Zeiss Meditec AGINTRABEAM® 600 — Carl Zeiss Meditec AGXstrahl 150 X-Ray System Floor — XSTRAHL LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-01 | Carl Zeiss Meditec AG | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. |
| 2023-02-10 | Sensus Healthcare, Inc. | When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient. |
| 2022-04-27 | Xstrahl Limited | There is a potential compatibility issue with the systems and replacement treatment applicators. |
| 2021-08-27 | Xstrahl Limited | Base plate may detach from the main body of the treatment applicator. |
| 2021-04-26 | Xstrahl Limited | If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulti |
| 2017-08-30 | Carl Zeiss Meditec AG | The device had an incorrect printed calibration value on the calibration certificate. |
| 2012-10-25 | Carl Zeiss Meditec, Inc. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| 2012-10-25 | Carl Zeiss Meditec, Inc. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| 2012-10-25 | Carl Zeiss Meditec, Inc. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| 2011-07-01 | Carl Zeiss Meditec, Inc. | Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethy |
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