VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA— 510(k) K980959

Name: FDA 510(k) clearance K980959
Creator: U.S. Food and Drug Administration
Published: 1998-06-04

Substantially Equivalent

Ge Medical Systems F.I. Haifa

FDA 510(k) clearance K980959 for VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA, Substantially Equivalent on 1998-06-04. Applicant: Ge Medical Systems F.I. Haifa. Device class: 2.

Clearance details

Applicant: Ge Medical Systems F.I. Haifa
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1998-03-14
Decision date: 1998-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

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