510(k) · Cleared
Recalled · Class II · 2026Intrabeam System with Intrabeam Spherical Applicators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · JAD System, Therapeutic, X-Ray
Cleared on Dec 27, 2012 as substantially equivalent to K992577 (Photoelectron Corporation, 1999) and 3 other predicates after a 205-day review. Its family tree reaches back 9 generations to 1986. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 27, 2012
- Review
- 205 days
- Class
- Class II
- Product code
- JAD
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 9 generations to K864210 (1986). 34 ancestors in all, the oldest K852907 (1985). 8 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 5 generations between
- 3 generations backK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
- 2 generations backK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
- 1 generation backK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- This deviceK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
- Descendant · 2 generations on · 4 of its ownK153368 Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016
- Descendant · 3 generations on · 3 of its ownK171885 Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017
- Descendant · cites it directly · 1 of its ownK162568 Intrabeam 600Carl Zeiss Meditec, AG · 2016
- Descendant · cites it directly · 0 of its ownK241174 INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM…Carl Zeiss Meditec, AG · 2025
Show all 9 generations
- Root · 9 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 8 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 7 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 6 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 5 generations backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- 4 generations backK041929 Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- 3 generations backK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
- 2 generations backK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
- 1 generation backK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- This deviceK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014 · cites it directly5descendants
- K153368Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016 · 2 generations on4descendants
- K171885Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017 · 3 generations on3descendants
- K162568Intrabeam 600Carl Zeiss Meditec, AG · 2016 · cites it directly1descendant
- K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −8 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −7 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −6 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −5 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| −4 | K041929 | Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| −3 | K071229 | Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy | Senorx, Inc. | 2007 | — |
| −2 | K081079 | Contura MLB Source Applicator for Brachytherapy | Senorx, Inc. | 2008 | — |
| −1 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
| 0 (this device) | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | — |
| +1 | K133655 | Radiance V2 | Gmv Soluciones Globales Internet S.A.U. | 2014 | — |
| +2 | K153368 | Radiance V3 | Gmv Soluciones Globales Internet S.A.U. | 2016 | — |
| +3 | K171885 | Radiance V4 | Gmv Soluciones Globales Internet S.A.U. | 2017 | — |
| +1 | K162568 | Intrabeam 600 | Carl Zeiss Meditec, AG | 2016 | — |
| +1 | K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART… | Carl Zeiss Meditec, AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAD device
- #1 K241174 INTRABEAM (700); And accessories (INTRABEAM…score 11.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992577 | Photon Radiosurgery System (PRS)Summary page 1…ny: Carl Zeiss Meditec AG Device: INTRABEAM® System with INTRABEAM® Spherical Applicators, K992577, K05 1055 Company: Hologic, Inc. Device: MammoSite Radiation Therapy System, KOl… | 1999 |
| * | K051055 | Intrabeam SystemSummary page 1…Carl Zeiss Meditec AG Device: INTRABEAM® System with INTRABEAM® Spherical Applicators, K992577, K05 1055 Company: Hologic, Inc. Device: MammoSite Radiation Therapy System, KOl 1690, K091… | 2005 |
| * | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray | 2002 |
| * | K091378 | Mammosite II Radiation Therapy SystemSummary page 1…Applicators, K992577, K05 1055 Company: Hologic, Inc. Device: MammoSite Radiation Therapy System, KOl 1690, K091378 Carl Zeiss Meditec INTRABEAM System with Premarket Notification 5… | 2009 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2026 | Class II | Z-2649-2026 | Employee error | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. |
| Aug 30, 2017 | Class II | Z-0001-2018 | Process control | The device had an incorrect printed calibration value on the calibration certificate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 34 ancestors have a recall of any class.
- Of its descendants, K133655 (Gmv Soluciones Globales Internet S.A.U., 2014) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K992577.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JAD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAD
114in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAD
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAD
1in 2025
MAUDE reports naming product code JAD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 106 | 2 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 3 |
| 2012 | 2 | — | 3 | 4 |
| 2013 | 5 | 114 | 0 | 12 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121653: Intrabeam System with Intrabeam Spherical Applicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121653
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026