K241174
- 510(k) number
- K241174
- Device name
- INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
- Applicant
- Carl Zeiss Meditec, AG DE
- Product code
- JAD — System, Therapeutic, X-Ray
- Decision date
- 2025-01-10
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241174.pdf
Official FDA record: K241174
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.