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FDA 510(k)

MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM

K-Number: K003575 · 2001-01-17

ApplicantGE Medical Systems
Decision Date2001-01-17
Product CodeLNI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM 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 2001-01-17 under 510(k) number K003575. The device is classified under product code LNI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM?

MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-01-17. The listed applicant is GE Medical Systems. The 510(k) number is K003575.

When did MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM received FDA 510(k) clearance on 2001-01-17, under 510(k) number K003575.

Who is the listed applicant for MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM?

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 MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM?

The FDA product code for MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM is LNI.

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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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