510(k) · Cleared
ClearedIntrabeam 600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · JAD System, Therapeutic, X-Ray
Cleared on Dec 15, 2016 as substantially equivalent to K051055 (Carl Zeiss Surgical GmbH, 2005) and 4 other predicates after a 92-day review. Its family tree reaches back 10 generations to 1986. 1 later device descends from it.
- Decided
- Dec 15, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K864210 (1986). 40 ancestors in all, the oldest K852907 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 6 generations between
- 3 generations backK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
- 2 generations backK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- 1 generation backK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- This deviceK162568 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 10 generations
- Root · 10 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 9 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 8 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 7 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 6 generations backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- 5 generations backK041929 Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- 4 generations backK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
- 3 generations backK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
- 2 generations backK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- 1 generation backK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- This deviceK162568 Intrabeam 600Carl Zeiss Meditec, AG · 2016
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −10 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −9 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −8 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −7 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −6 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| −5 | K041929 | Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| −4 | K071229 | Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy | Senorx, Inc. | 2007 | — |
| −3 | K081079 | Contura MLB Source Applicator for Brachytherapy | Senorx, Inc. | 2008 | — |
| −2 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
| −1 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| 0 (this device) | 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 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K051055 | Intrabeam SystemSummary page 4…Class II, X-ray radiation therapy system Regulation: Panel: Radiology Product Code: JAD - Therapeutic X-ray System Primary Predicate: K051055 - INTRABEAM System Additional K090584 – INTRABEAM System Predicates: K110590 – INTRABEAM System w/ Need… | 2005 |
| * | K090584 | Intrabeam System with Balloon Applicator and CBG SetsSummary page 4…: Panel: Radiology Product Code: JAD - Therapeutic X-ray System Primary Predicate: K051055 - INTRABEAM System Additional K090584 – INTRABEAM System Predicates: K110590 – INTRABEAM System w/ Needle Applicator K121653 – INTR… | 2009 |
| * | K110590 | Intrabeam Needle ApplicatorSummary page 4…: JAD - Therapeutic X-ray System Primary Predicate: K051055 - INTRABEAM System Additional K090584 – INTRABEAM System Predicates: K110590 – INTRABEAM System w/ Needle Applicator K121653 – INTRABEAM System w/ Spherical Applicators… | 2012 |
| * | K121653 | Intrabeam System with Intrabeam Spherical ApplicatorsSummary page 4…55 - INTRABEAM System Additional K090584 – INTRABEAM System Predicates: K110590 – INTRABEAM System w/ Needle Applicator K121653 – INTRABEAM System w/ Spherical Applicators K130549 – INTRABEAM System w/ Flat and Surface Applicators… | 2012 |
| * | K130549 | Intrabeam Flat Applicator, Intrabeam Surface ApplicatorSummary page 4…redicates: K110590 – INTRABEAM System w/ Needle Applicator K121653 – INTRABEAM System w/ Spherical Applicators K130549 – INTRABEAM System w/ Flat and Surface Applicators Reference Predicate: K153368 – Radiance V3 Indication for Use:… | 2013 |
| † | K153368 | Radiance V3 | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 9 of the 40 ancestors have a recall of any class.
- Of its descendants, K241174 (Carl Zeiss Meditec, AG, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051055.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 600 is indicated for radiation therapy treatments. The INTRABEAM Spherical Applicators are indicated for use with the INTRABEAM 600 to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments. The INTRABEAM Spherical Applicators used with the INTRABEAM 600 are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast…
Read the full statement (258 words)
The INTRABEAM 600 is indicated for radiation therapy treatments.
The INTRABEAM Spherical Applicators are indicated for use with the INTRABEAM 600 to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.
The INTRABEAM Spherical Applicators used with the INTRABEAM 600 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 600 as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
The Needle Applicator set (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM 600 to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
The INTRABEAM Flat Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600,
• during intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed.
• during treatment of tumors on the body surface.
The INTRABEAM Flat Applicator is designed to deliver a flat radiation field at a distance of 5mm from its circular application surface in water.
The INTRABEAM Surface Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600.
• 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162568: Intrabeam 600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162568
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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