ISOCAM II (DUAL HEAD GAMMA CAMERA)— 510(k) K940487

Name: FDA 510(k) clearance K940487
Creator: U.S. Food and Drug Administration
Published: 1994-09-30

Substantially Equivalent

Independent Scintilation Imaging Systems, Inc.

FDA 510(k) clearance K940487 for ISOCAM II (DUAL HEAD GAMMA CAMERA), Substantially Equivalent on 1994-09-30. Applicant: Independent Scintilation Imaging Systems, Inc.. Device class: 2.

Clearance details

Applicant: Independent Scintilation Imaging Systems, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1994-02-03
Decision date: 1994-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lachine Quebec, CA

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