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FDA 510(k)

HELAX TMS BRACHYTHERAPY, VERSION 3.0

K-Number: K962892 · 1996-10-29

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1996-10-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HELAX TMS BRACHYTHERAPY, VERSION 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1996-10-29 under 510(k) number K962892. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELAX TMS BRACHYTHERAPY, VERSION 3.0?

HELAX TMS BRACHYTHERAPY, VERSION 3.0 is a medical device that received FDA 510(k) clearance on 1996-10-29. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K962892.

When did HELAX TMS BRACHYTHERAPY, VERSION 3.0 receive FDA 510(k) clearance?

HELAX TMS BRACHYTHERAPY, VERSION 3.0 received FDA 510(k) clearance on 1996-10-29, under 510(k) number K962892.

Who is the listed applicant for HELAX TMS BRACHYTHERAPY, VERSION 3.0?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HELAX TMS BRACHYTHERAPY, VERSION 3.0?

The FDA product code for HELAX TMS BRACHYTHERAPY, VERSION 3.0 is LNH.

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Official Source

View on FDA Database →

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