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FDA 510(k)

ISAAC 1.5 T MR SYSTEM

K-Number: K020268 · 2002-04-25

ApplicantChi, Inc.
Decision Date2002-04-25
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISAAC 1.5 T MR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Chi, Inc.. It received FDA 510(k) clearance on 2002-04-25 under 510(k) number K020268. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISAAC 1.5 T MR SYSTEM?

ISAAC 1.5 T MR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-04-25. The listed applicant is Chi, Inc.. The 510(k) number is K020268.

When did ISAAC 1.5 T MR SYSTEM receive FDA 510(k) clearance?

ISAAC 1.5 T MR SYSTEM received FDA 510(k) clearance on 2002-04-25, under 510(k) number K020268.

Who is the listed applicant for ISAAC 1.5 T MR SYSTEM?

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

What is the FDA product code for ISAAC 1.5 T MR SYSTEM?

The FDA product code for ISAAC 1.5 T MR SYSTEM is LNH.

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Official Source

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

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