# K130549: Intrabeam Flat Applicator, Intrabeam Surface Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Jun 26, 2013 after 114 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864210 (1986). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083734: Axxent Surface Applicator, Model 710257, Xoft, Inc. (2009) Summary page 1.

## Most influential descendants
- 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.

## Indications for use
The INTRABEAM® Surface Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System. 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/K130549
Methodology: https://510kreport.com/methodology