# K241174: INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Jan 10, 2025 after 259 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K864210 (1986). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162568: Intrabeam 600, Carl Zeiss Meditec, AG (2016) Summary page 6.
- K121653: Intrabeam System with Intrabeam Spherical Applicators, Carl Zeiss Meditec, Inc. (2012) Summary page 11.

## Indications for use
The INTRABEAM is intended for use in radiotherapy treatments. The INTRABEAM SMART Spherical Applicator is used with the INTRABEAM to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments. The safety and effectiveness of the INTRABEAM as a replacement for whole breast irradiation in the treatment of breast cancer has not been established. The INTRABEM Needle Applicator (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM to intraoperatively administer radiation to tissue including irradiation of intracranial tumors. The INTRABEAM SMART Stand is designed as an instrument support and positioning unit for the INTRABEAM. The INTRABEAM Spherical Sizer Set shall support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.

Source page: https://510kreport.com/device/K241174
Methodology: https://510kreport.com/methodology