Ct-Modeller System

FDA 510(k) K970617 · Materialise NV

Substantially Equivalent

510(k) numberK970617

Submission

Device name
Ct-Modeller System
Applicant
Materialise NV
Garland, TX, US
Received
February 18, 1997
Decision date
April 21, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Ct-Modeller System cleared by the FDA?

Ct-Modeller System (K970617) received a 510(k) decision of Substantially Equivalent on April 21, 1997, 62 days after the submission was received.

What is the product code of K970617?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.