# K121653: Intrabeam System with Intrabeam Spherical Applicators

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Dec 27, 2012 after 205 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: 9 generations back to K864210 (1986). 34 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992577: Photon Radiosurgery System (PRS), Photoelectron Corporation (1999) Summary page 1.
- K051055: Intrabeam System, Carl Zeiss Surgical GmbH (2005) Summary page 1.
- K011690: Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2002)
- K091378: Mammosite II Radiation Therapy System, Hologic, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- 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
- Jun 1, 2026 · Class II · Z-2649-2026: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
- 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® 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 and intraoperative radiotherapy treatments. The INTRABEAM® Spherical Applicators used with the INTRABEAM System 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 System as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

Source page: https://510kreport.com/device/K121653
Methodology: https://510kreport.com/methodology