Intrabeam System with Balloon Applicator and CBG Sets
FDA 510(k) K090584 · Carl Zeiss Surgical GmbH
510(k) numberK090584
Submission
- Device name
- Intrabeam System with Balloon Applicator and CBG Sets
- Applicant
- Carl Zeiss Surgical GmbH
North Attleboro, MA, US - Received
- March 3, 2009
- Decision date
- November 24, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250692 | GentleBeam (GB1000)JAD · Traditional | Voxel Ray Solutions, LLC | 12/03/2025SE |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…JAD · Traditional | Carl Zeiss Meditec, AG | 01/10/2025SE |
| K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)JAD · Traditional | Xstrahl, Ltd. | 07/13/2023SE |
| K213942 | EsteyaJAD · Traditional | Nucletron B.V. | 01/11/2022SE |
| K190255 | Sensus Healthcare TVM Balloon ApplicatorJAD · Traditional | Sensus Healthcare, Inc. | 02/21/2019SE |
| K182641 | Sensus IORT SystemJAD · Traditional | Sensus Healthcare, Inc. | 02/21/2019SE |
| K173425 | SRT-100+JAD · Traditional | Sensus Healthcare, Inc. | 03/23/2018SE |
| K172080 | Photoelectric Therapy SystemJAD · Traditional | Xstrahl, Ltd. | 09/29/2017SE |
| K162568 | Intrabeam 600JAD · Traditional | Carl Zeiss Meditec, AG | 12/15/2016SE |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200JAD · Traditional | Icad, Inc. | 02/25/2016SE |
More from Icad, Inc.
Questions and answers
When was Intrabeam System with Balloon Applicator and CBG Sets cleared by the FDA?
Intrabeam System with Balloon Applicator and CBG Sets (K090584) received a 510(k) decision of Substantially Equivalent on November 24, 2009, 266 days after the submission was received.
What is the product code of K090584?
The FDA product code is JAD – System, Therapeutic, X-Ray, a Class II (moderate risk) device regulated under 21 CFR 892.5900.