SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM— 510(k) K063456

Substantially Equivalent

Topex, Inc.

FDA 510(k) clearance K063456 for SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM, Substantially Equivalent on 2007-01-09. Applicant: Topex, Inc.. Device class: 2.

Clearance details

Applicant
Topex, Inc.
Product code
Code JAD
Device class
Class 2
Regulation
21 CFR 892.5900
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Danbury, CT, US
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