DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)— 510(k) K973411

Name: FDA 510(k) clearance K973411
Creator: U.S. Food and Drug Administration
Published: 1997-12-04

Substantially Equivalent

General Scanning, Inc.

FDA 510(k) clearance K973411 for DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME), Substantially Equivalent on 1997-12-04. Applicant: General Scanning, Inc.. Device class: 2.

Clearance details

Applicant: General Scanning, Inc.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 1997-09-09
Decision date: 1997-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

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