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FDA 510(k)

INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS

K-Number: K121653 · 2012-12-27

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2012-12-27
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2012-12-27 under 510(k) number K121653. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS?

INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS is a medical device that received FDA 510(k) clearance on 2012-12-27. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K121653.

When did INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS receive FDA 510(k) clearance?

INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS received FDA 510(k) clearance on 2012-12-27, under 510(k) number K121653.

Who is the listed applicant for INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS?

The FDA 510(k) record lists Carl Zeiss Meditec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS?

The FDA product code for INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS is JAD.

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Related Devices (Code: JAD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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