# K110590: Intrabeam Needle Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Surgical GmbH
- Decided: Apr 13, 2012 after 408 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: 2 generations back to K964947 (1997). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980526: Photon Radiosurgery System PRS400, Pec Photoelectron Corp. (1998) Summary page 1.
- K090584: Intrabeam System with Balloon Applicator and CBG Sets, Carl Zeiss Surgical GmbH (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 Needle Applicator set (comprising the Needle Applicator and guide shaft) is indicated for use in combination with the INTRABEAM System to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.

Source page: https://510kreport.com/device/K110590
Methodology: https://510kreport.com/methodology