# K090584: Intrabeam System with Balloon Applicator and CBG Sets

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Surgical GmbH
- Decided: Nov 24, 2009 after 266 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K110590: Intrabeam Needle Applicator (2012), 2 descendants of its own
- K162568: Intrabeam 600 (2016), 1 descendant of its own
- 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

## Recalls of this device
- Aug 30, 2017 · Class II · Z-0001-2018: The device had an incorrect printed calibration value on the calibration certificate.
- Oct 25, 2012 · Class II · Z-0404-2013: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
- Oct 25, 2012 · Class II · Z-0405-2013: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
- Oct 25, 2012 · Class II · Z-0406-2013: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
- Jul 1, 2011 · Not classified · Z-2989-2011: Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol,

## Indications for use
The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use. with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavitary or intraoperative radiotherapy treatments. The INTRABEAM® Balloon Applicator together with the LNTRABEAM® System is intended to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer. The safety and effectiveness of the INTRABEAM® System as a replacement for whole breast irradiation in the treatment of breast cancer has not yet been established.

Source page: https://510kreport.com/device/K090584
Methodology: https://510kreport.com/methodology