FDA 510(k) Premarket Notification K241174: INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)

Submission Details & Decision

Normalized public record details for 510(k) notification K241174.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K241174

Applicant / Sponsor

Carl Zeiss Meditec, AG

Device Name

INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)

Product Code

JAD

Decision Date

2025-01-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2024-04-26

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