Intrabeam Needle Applicator
FDA 510(k) K110590 · Carl Zeiss Surgical GmbH
510(k) numberK110590
Submission
- Device name
- Intrabeam Needle Applicator
- Applicant
- Carl Zeiss Surgical GmbH
Dublin, CA, US - Received
- March 2, 2011
- Decision date
- April 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAD
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|---|---|---|---|
| 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 |
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Questions and answers
When was Intrabeam Needle Applicator cleared by the FDA?
Intrabeam Needle Applicator (K110590) received a 510(k) decision of Substantially Equivalent on April 13, 2012, 408 days after the submission was received.
What is the product code of K110590?
The FDA product code is JAD – System, Therapeutic, X-Ray, a Class II (moderate risk) device regulated under 21 CFR 892.5900.