# K051055: Intrabeam System

- Pathway: 510(k) (Special)
- Applicant: Carl Zeiss Surgical GmbH
- Decided: May 23, 2005 after 27 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K864210 (1986). 9 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 19 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.
- K992577: Photon Radiosurgery System (PRS), Photoelectron Corporation (1999) Summary page 1.

## Most influential descendants
- K121653: Intrabeam System with Intrabeam Spherical Applicators (2012), 8 descendants of its own
- K133655: Radiance V2 (2014), 5 descendants of its own
- K153368: Radiance V3 (2016), 4 descendants of its own
- K171885: Radiance V4 (2017), 3 descendants of its own
- K162568: Intrabeam 600 (2016), 1 descendant 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.
- 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 intracavity or intraoperative radiotherapy treatments.

Source page: https://510kreport.com/device/K051055
Methodology: https://510kreport.com/methodology