FDA 510(k)

CT-MODELLER SYSTEM

K-Number: K970617 · 1997-04-21

Decision Date1997-04-21

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CT-MODELLER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 1997-04-21 under 510(k) number K970617. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT-MODELLER SYSTEM?

CT-MODELLER SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Materialise NV. The 510(k) number is K970617.

When did CT-MODELLER SYSTEM receive FDA 510(k) clearance?

CT-MODELLER SYSTEM received FDA 510(k) clearance on 1997-04-21, under 510(k) number K970617.

Who is the listed applicant for CT-MODELLER SYSTEM?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT-MODELLER SYSTEM?

The FDA product code for CT-MODELLER SYSTEM is LLZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.