TOMOPHASE OCTIS— 510(k) K102599

Substantially Equivalent

Tomophase Corporation

FDA 510(k) clearance K102599 for TOMOPHASE OCTIS, Substantially Equivalent on 2010-12-01. Applicant: Tomophase Corporation. Device class: 2.

Clearance details

Applicant
Tomophase Corporation
Product code
Code NQQ
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hampton, NH, US
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