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FDA 510(k)

SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY

K-Number: K013636 · 2002-01-24

ApplicantGE Medical Systems
Decision Date2002-01-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2002-01-24 under 510(k) number K013636. 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 SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY?

SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY is a medical device that received FDA 510(k) clearance on 2002-01-24. The listed applicant is GE Medical Systems. The 510(k) number is K013636.

When did SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY receive FDA 510(k) clearance?

SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY received FDA 510(k) clearance on 2002-01-24, under 510(k) number K013636.

Who is the listed applicant for SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY?

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

What is the FDA product code for SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY?

The FDA product code for SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY is LNH.

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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.

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