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FDA 510(k)

GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS

K-Number: K033867 · 2003-12-19

ApplicantGeneral Electric Co.
Decision Date2003-12-19
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K033867. 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 GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS?

GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is General Electric Co.. The 510(k) number is K033867.

When did GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS receive FDA 510(k) clearance?

GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS received FDA 510(k) clearance on 2003-12-19, under 510(k) number K033867.

Who is the listed applicant for GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS?

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

What is the FDA product code for GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS?

The FDA product code for GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS is LNH.

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Other records listing General Electric Co. as applicant

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K103489GE VEO RECONSTRUCTION OPTIONK082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTIONK081921GE VIVID E9 ULTRASOUNDK073297GE LOGIQ P6K072952GE ECHOPACK072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

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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.

K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K261283APERTO Lucent MRI SystemFujifilm CorporationK260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems

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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