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FDA 510(k)

SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM

K-Number: K063456 · 2007-01-09

ApplicantTopex, Inc.
Decision Date2007-01-09
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Topex, Inc.. It received FDA 510(k) clearance on 2007-01-09 under 510(k) number K063456. 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 SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM?

SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-09. The listed applicant is Topex, Inc.. The 510(k) number is K063456.

When did SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM receive FDA 510(k) clearance?

SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM received FDA 510(k) clearance on 2007-01-09, under 510(k) number K063456.

Who is the listed applicant for SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM?

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

What is the FDA product code for SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM?

The FDA product code for SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM is JAD.

Related Clinical Trials

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.

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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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