GATED MIBI 3-D EJECTION FRACTION PROCESSING— 510(k) K961597

Substantially Equivalent

Trionix Research Laboratory, Inc.

FDA 510(k) clearance K961597 for GATED MIBI 3-D EJECTION FRACTION PROCESSING, Substantially Equivalent on 1996-09-04. Applicant: Trionix Research Laboratory, Inc..

Clearance details

Applicant: Trionix Research Laboratory, Inc.
Product code: Code KPS
Advisory panel: Radiology
Date received: 1996-04-24
Decision date: 1996-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

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