INTRABEAM (700) +1 more— 510(k) K241174
Substantially EquivalentCarl Zeiss Meditec, AG
FDA 510(k) clearance K241174 for INTRABEAM (700) +1 more, Substantially Equivalent on 2025-01-10. Applicant: Carl Zeiss Meditec, AG. Device class: 2.
Clearance details
- Device name as filed
- INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
- Applicant
- Carl Zeiss Meditec, AG
- Product code
- Code JAD
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oberkochen, DE
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