IMAGEFUSION 2.0— 510(k) K990071

Substantially Equivalent

Radionics, Inc.

FDA 510(k) clearance K990071 for IMAGEFUSION 2.0, Substantially Equivalent on 1999-02-08. Applicant: Radionics, Inc.. Device class: 2.

Clearance details

Applicant: Radionics, Inc.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1999-01-11
Decision date: 1999-02-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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