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FDA 510(k)

1.5T INFINITY TWINSPEED MR SYSTEM

K-Number: K012200 · 2001-08-03

ApplicantGE Medical Systems
Decision Date2001-08-03
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T INFINITY TWINSPEED MR 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 2001-08-03 under 510(k) number K012200. 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 1.5T INFINITY TWINSPEED MR SYSTEM?

1.5T INFINITY TWINSPEED MR SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-03. The listed applicant is GE Medical Systems. The 510(k) number is K012200.

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

1.5T INFINITY TWINSPEED MR SYSTEM received FDA 510(k) clearance on 2001-08-03, under 510(k) number K012200.

Who is the listed applicant for 1.5T INFINITY TWINSPEED MR 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 1.5T INFINITY TWINSPEED MR SYSTEM?

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

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Other records listing GE Medical Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLK220848Venue FitK220851VenueK173341Vivid E80, Vivid E90, Vivid E95K103411IDEAL IQ SOFTWARE OPTIONK073138CARDIQ EXPRESS VERSION 2.0

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Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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