Intrabeam System

FDA 510(k) K051055 · Carl Zeiss Surgical GmbH

Substantially Equivalent

510(k) numberK051055

Submission

Device name
Intrabeam System
Applicant
Carl Zeiss Surgical GmbH
North Attleboro, MA, US
Received
April 26, 2005
Decision date
May 23, 2005
Decision
Substantially Equivalent (SESE)
Type
Special 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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K182641Sensus IORT SystemJAD · Traditional Sensus Healthcare, Inc.02/21/2019SE
K173425SRT-100+JAD · Traditional Sensus Healthcare, Inc.03/23/2018SE
K172080Photoelectric Therapy SystemJAD · Traditional Xstrahl, Ltd.09/29/2017SE
K162568Intrabeam 600JAD · Traditional Carl Zeiss Meditec, AG12/15/2016SE
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More from Icad, Inc.

510(k)DeviceDecision
K110590Intrabeam Needle ApplicatorJAD · Traditional 04/13/2012SE
K100468Zeiss Infrared 800 with Flow 800 OptionIZI · Traditional 03/03/2010SE
K090584Intrabeam System with Balloon Applicator and CBG SetsJAD · Traditional 11/24/2009SE

Questions and answers

When was Intrabeam System cleared by the FDA?

Intrabeam System (K051055) received a 510(k) decision of Substantially Equivalent on May 23, 2005, 27 days after the submission was received.

What is the product code of K051055?

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