510(k) · Cleared
ClearedINTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
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 Jan 10, 2025 as substantially equivalent to K162568 (Carl Zeiss Meditec, AG, 2016) and 1 other predicate after a 259-day review. Its family tree reaches back 11 generations to 1986.
- Decided
- Jan 10, 2025
- Review
- 259 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K864210 (1986). 41 ancestors in all, the oldest K852907 (1985). No later device cites it as a predicate yet.
- Root · 11 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 7 generations between
- 3 generations backK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- 2 generations backK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- 1 generation backK162568 Intrabeam 600Carl Zeiss Meditec, AG · 2016
- This deviceK241174 INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM…Carl Zeiss Meditec, AG · 2025
Show all 11 generations
- Root · 11 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 10 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 9 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 8 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 7 generations backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- 6 generations backK041929 Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- 5 generations backK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
- 4 generations backK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
- 3 generations backK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- 2 generations backK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- 1 generation backK162568 Intrabeam 600Carl Zeiss Meditec, AG · 2016
- This deviceK241174 INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM…Carl Zeiss Meditec, AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −10 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −9 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −8 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −7 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| −6 | K041929 | Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| −5 | K071229 | Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy | Senorx, Inc. | 2007 | — |
| −4 | K081079 | Contura MLB Source Applicator for Brachytherapy | Senorx, Inc. | 2008 | — |
| −3 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
| −2 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| −1 | K162568 | Intrabeam 600 | Carl Zeiss Meditec, AG | 2016 | — |
| 0 (this device) | 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 |
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 K250692 GentleBeam (GB1000)score 11.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K162568 | Intrabeam 600Summary page 6…system Regulatory Class: II Product Code: JAD 3. LEGAL MARKETED PREDICATE DEVICE Predicate Device Name: INTRABEAM 600 (K162568) Classification: 21 CFR 892.5900 X-ray radiation therapy system Regulatory Class: II Product Code:… | 2016 |
| * | K121653 | Intrabeam System with Intrabeam Spherical ApplicatorsSummary page 11…ble − INTRABEAM SMART − INTRABEAM Spherical Equivalent – new Applicators Spherical Applicator Applicator (K121653) compatible applicator (K241174) − INTRABEAM Flat is… | 2012 |
| † | K951764 | Unidos Universal Dosimeter Model 10002-with TNC Connector, 10005-with BNT Connector | 1995 |
| † | K171885 | Radiance V4 | 2017 |
| † | K233236 | Radiance V5 | 2024 |
| † | K130549 | Intrabeam Flat Applicator, Intrabeam Surface Applicator | 2013 |
| † | K110590 | Intrabeam Needle Applicator | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 9 of the 41 ancestors have a recall of any class.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 is intended for use in radiotherapy treatments. The INTRABEAM SMART Spherical Applicator is used with the INTRABEAM to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments. The safety and effectiveness of the INTRABEAM as a replacement for whole breast irradiation in the treatment of breast cancer has not been established. The INTRABEM Needle…
Read the full statement (139 words)
The INTRABEAM is intended for use in radiotherapy treatments.
The INTRABEAM SMART Spherical Applicator is used with the INTRABEAM to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.
The safety and effectiveness of the INTRABEAM as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
The INTRABEM Needle Applicator (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
The INTRABEAM SMART Stand is designed as an instrument support and positioning unit for the INTRABEAM.
The INTRABEAM Spherical Sizer Set shall support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241174: INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241174
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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