510(k) · Cleared
Recalled · Class II · 2017Intrabeam System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Surgical GmbH · JAD System, Therapeutic, X-Ray
Cleared on May 23, 2005 as substantially equivalent to K980526 (Pec Photoelectron Corp., 1998) and 1 other predicate after a 27-day review. Its family tree reaches back 3 generations to 1986. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- May 23, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- JAD
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K864210 (1986). 9 ancestors in all, the oldest K852907 (1985). 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 2 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 1 generation backK992577 Photon Radiosurgery System (PRS)Photoelectron Corporation · 1999
- This deviceK051055 Intrabeam SystemCarl Zeiss Surgical GmbH · 2005
- Descendant · cites it directly · 8 of its ownK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
- Descendant · 3 generations on · 4 of its ownK153368 Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016
- Descendant · 4 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
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · cites it directly8descendants
- K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014 · 2 generations on5descendants
- K153368Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016 · 3 generations on4descendants
- K171885Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017 · 4 generations on3descendants
- K162568Intrabeam 600Carl Zeiss Meditec, AG · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −2 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −1 | K992577 | Photon Radiosurgery System (PRS) | Photoelectron Corporation | 1999 | — |
| 0 (this device) | K051055 | Intrabeam System | Carl Zeiss Surgical GmbH | 2005 | — |
| +1 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| +2 | K133655 | Radiance V2 | Gmv Soluciones Globales Internet S.A.U. | 2014 | — |
| +3 | K153368 | Radiance V3 | Gmv Soluciones Globales Internet S.A.U. | 2016 | — |
| +4 | K171885 | Radiance V4 | Gmv Soluciones Globales Internet S.A.U. | 2017 | — |
| +1 | K162568 | Intrabeam 600 | Carl Zeiss Meditec, AG | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K980526 | Photon Radiosurgery System PRS400Summary page 1…al Name: X-Ray Radiation Therapy Control Unit Classification Name: X-ray Radiation Therapy Systems and Accessories 3. PREDICATE DEVICES PRS400 System (K980526 qnd K992577) 4. DEVICE DESCRIPTION The INTRABEAM® System described in this Special 510(k) is a modification a… | 1998 |
| * | K992577 | Photon Radiosurgery System (PRS)Summary page 1…ay Radiation Therapy Control Unit Classification Name: X-ray Radiation Therapy Systems and Accessories 3. PREDICATE DEVICES PRS400 System (K980526 qnd K992577) 4. DEVICE DESCRIPTION The INTRABEAM® System described in this Special 510(k) is a modification and enhanceme… | 1999 |
What descends from it? (9)
2 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 |
|---|---|---|---|---|
| Aug 30, 2017 | Class II | Z-0001-2018 | Process control | The device had an incorrect printed calibration value on the calibration certificate. |
| Jul 1, 2011 | Not classified | Z-2989-2011 | Process control | 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, |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K121653 (Carl Zeiss Meditec, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K980526.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intracavity or intraoperative radiotherapy treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051055 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051055: Intrabeam System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051055
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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