# K162568: Intrabeam 600

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Dec 15, 2016 after 92 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: 10 generations back to K864210 (1986). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051055: Intrabeam System, Carl Zeiss Surgical GmbH (2005) Summary page 4.
- K090584: Intrabeam System with Balloon Applicator and CBG Sets, Carl Zeiss Surgical GmbH (2009) Summary page 4.
- K110590: Intrabeam Needle Applicator, Carl Zeiss Surgical GmbH (2012) Summary page 4.
- K121653: Intrabeam System with Intrabeam Spherical Applicators, Carl Zeiss Meditec, Inc. (2012) Summary page 4.
- K130549: Intrabeam Flat Applicator, Intrabeam Surface Applicator, Carl Zeiss Meditec, Inc. (2013) Summary page 4.

## Most influential descendants
- K241174: INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (2025), 0 descendants of its own

## Indications for use
The INTRABEAM 600 is indicated for radiation therapy treatments. The INTRABEAM Spherical Applicators are indicated for use with the INTRABEAM 600 to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments. The INTRABEAM Spherical Applicators used with the INTRABEAM 600 are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM 600 as a replacement for whole breast irradiation in the treatment of breast cancer has not been established. The Needle Applicator set (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM 600 to intraoperatively administer radiation to tissue including irradiation of intracranial tumors. The INTRABEAM Flat Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600, • during intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed. • during treatment of tumors on the body surface. The INTRABEAM Flat Applicator is designed to deliver a flat radiation field at a distance of 5mm from its circular application surface in water. The INTRABEAM Surface Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600. • during intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed. • during treatment of tumors on the body surface. The INTRABEAM Surface Applicator is designed to deliver a flat radiation field directly at the applicator's surface.

Source page: https://510kreport.com/device/K162568
Methodology: https://510kreport.com/methodology