510(k) K090584
- Device
- INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
- Applicant
- CARL ZEISS SURGICAL GMBH
- 510(k) number
- K090584
- Product code
- JAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-24
- Date received
- 2009-03-03
- Regulation
- 892.5900
- Classification name
- System, Therapeutic, X-ray
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK W SHEEHAN
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 3005770916
- 3036107971
- 3009732568
- 1181047
- 3023344262
- 3004561814
- 3010653929
- 3008513398
- 2320968
- 3006017180
- 1219183
- 3009039068
- 3015232217
- 3009539885
- 2953359
- 3005562917
- 9615010
- 3032638959
- 9611894
- 3030230020
Source Documents#
Other 510(k) Records For Product Code JAD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | 2025-12-03 |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | Carl Zeiss Meditec, AG | 2025-01-10 |
| K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | Xstrahl, Ltd. | 2023-07-13 |
| K213942 | Esteya | Nucletron B.V. | 2022-01-11 |
| K190255 | Sensus Healthcare TVM Balloon Applicator | Sensus Healthcare, Inc. | 2019-02-21 |
| K182641 | Sensus IORT System | Sensus Healthcare, Inc. | 2019-02-21 |
| K173425 | SRT-100+ | Sensus Healthcare, Inc. | 2018-03-23 |
| K172080 | Photoelectric Therapy System | Xstrahl, Ltd. | 2017-09-29 |
| K162568 | INTRABEAM 600 | Carl Zeiss Meditec, AG | 2016-12-15 |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | Icad, Inc. | 2016-02-25 |
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | Sensus Healthcare | 2015-10-16 |
| K141343 | AXXENT CERVICAL APPLICATOR | Icad, Inc. | 2014-09-05 |
| K132092 | ESTEYA | Nucletron B.V. | 2013-09-26 |
| K131582 | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM | Sensus Healthcare | 2013-08-28 |
| K130549 | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR | Carl Zeiss Meditec, Inc. | 2013-06-26 |
Legacy Summary#
summary
FDA Review#
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