IMAGE-X SYSTEM— 510(k) K012355

Substantially Equivalent

Tg Group, Inc.

FDA 510(k) clearance K012355 for IMAGE-X SYSTEM, Substantially Equivalent on 2001-08-09. Applicant: Tg Group, Inc.. Device class: 2.

Clearance details

Applicant: Tg Group, Inc.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2001-07-25
Decision date: 2001-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.