System, Therapeutic, X-Ray
Regulation 892.5900
1510(k)s in 12 months (53 all time)
1recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in JAD
| Company | 510(k)s | Recalls |
|---|---|---|
| Carl Zeiss Meditec, AG | 4 | 6 |
| Sensus Healthcare | 6 | 1 |
| Xoft, Inc. | 5 | 0 |
| Xstrahl, Ltd. | 2 | 3 |
| Action Products, Inc. | 1 | 2 |
| Carl Zeiss Surgical GmbH | 3 | 0 |
| Icad, Inc. | 3 | 0 |
| Adac Laboratories | 2 | 0 |
| Emi Therapy Systems, Inc. | 2 | 0 |
| Nucletron B.V. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Carl Zeiss Meditec AG Zeiss Intrabeam Spherical Applicator 1.5 cm
REF:304534-6000-557 Open, Classified |
JAD | K121653 |
| Mar 8, 2023 | Sensus Healthcare, Inc. Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities Terminated |
JAD | K150037 |
| Apr 27, 2022 | Xstrahl Limited X80 RADiant Photoelectric Therapy System Open, Classified |
JAD | K172080 |
| Aug 27, 2021 | Xstrahl Limited Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system Terminated |
JAD | K962613 |
| Apr 26, 2021 | Xstrahl Limited Concerto User Interface Software provided with the following systems:
(1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System;
(2) Xstrahl 150 Electronic Brachytherapy - 150 Terminated |
JAD | K172080 K962613 |
| Aug 30, 2017 | Carl Zeiss Meditec AG Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany.
The INTRABEAM System is indicated for radiation therapy treatments Terminated |
JAD | K051055 K090584 +3 |
| Nov 20, 2012 | Carl Zeiss Meditec, Inc. INTRABEAM Balloon Applicator Set;
4.0 cm,
Carl Zeiss Meditec AG, Oberkochen, Germany
INTRABEAM System is intended for radiation therapy treatments. Terminated |
JAD | K090584 |
| Nov 20, 2012 | Carl Zeiss Meditec, Inc. INTRABEAM Balloon Applicator Set;
3.5 cm,
Carl Zeiss Meditec AG, Oberkochen, Germany
INTRABEAM System is intended for radiation therapy treatments. Terminated |
JAD | K090584 |
| Nov 20, 2012 | Carl Zeiss Meditec, Inc. INTRABEAM Balloon Applicator Set;
3.0 cm,
Carl Zeiss Meditec AG, Oberkochen, Germany
INTRABEAM System is intended for radiation therapy treatments Terminated |
JAD | K090584 |
| Aug 10, 2011 | Carl Zeiss Meditec, Inc. INTRABEAM Shielding Material Flat 20 x 20 cm,
Sterile/FO
0.05 mm Pb Equivalent (50keV)
Carl Zeiss Meditec AG
Indicated for radiation therapy treatments. Terminated |
JAD | K051055 K090584 |
| Sep 22, 2009 | Action Products Incorporated Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy. Terminated |
JAD | K811528 |
| Sep 22, 2009 | Action Products Incorporated Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy. Terminated |
JAD | K811528 |
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