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

FDA 510(k) K241174 · Carl Zeiss Meditec, AG

Substantially Equivalent

510(k) numberK241174

Submission

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
Oberkochen, DE
Received
April 26, 2024
Decision date
January 10, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAD – System, Therapeutic, X-Ray
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5900
Specialty
Radiology

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Questions and answers

When was INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) cleared by the FDA?

INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (K241174) received a 510(k) decision of Substantially Equivalent on January 10, 2025, 259 days after the submission was received.

What is the product code of K241174?

The FDA product code is JAD – System, Therapeutic, X-Ray, a Class II (moderate risk) device regulated under 21 CFR 892.5900.