2000 X-RAY - TOMOGRAPHIC— 510(k) K931815

Substantially Equivalent

Imaging Sciences Intl., Inc.

FDA 510(k) clearance K931815 for 2000 X-RAY - TOMOGRAPHIC, Substantially Equivalent on 1993-08-23. Applicant: Imaging Sciences Intl., Inc.. Device class: 2.

Clearance details

Applicant
Imaging Sciences Intl., Inc.
Product code
Code IZF
Device class
Class 2
Regulation
21 CFR 892.1740
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gwynedd, PA, US
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