Cleared Traditional

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

K241174 · Carl Zeiss Meditec, AG · Radiology
Jan 2025
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K241174 is an FDA 510(k) clearance for the INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator), a System, Therapeutic, X-ray (Class II — Special Controls, product code JAD), submitted by Carl Zeiss Meditec, AG (Oberkochen, DE). The FDA issued a Cleared decision on January 10, 2025, 259 days after receiving the submission on April 26, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5900.

Submission Details

510(k) Number K241174 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2024
Decision Date January 10, 2025
Days to Decision 259 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAD — System, Therapeutic, X-ray
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5900