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FDA 510(k)

NEUROCAM

K-Number: K910967 · 1991-07-03

ApplicantGE Medical Systems
Decision Date1991-07-03
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEUROCAM 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 1991-07-03 under 510(k) number K910967. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROCAM?

NEUROCAM is a medical device that received FDA 510(k) clearance on 1991-07-03. The listed applicant is GE Medical Systems. The 510(k) number is K910967.

When did NEUROCAM receive FDA 510(k) clearance?

NEUROCAM received FDA 510(k) clearance on 1991-07-03, under 510(k) number K910967.

Who is the listed applicant for NEUROCAM?

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 NEUROCAM?

The FDA product code for NEUROCAM is IYX.

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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: IYX)

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.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXMHermes Medical Solutions ABK160933Discovery NM 750b BopsyGE HealthcareK162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-K123408ERGO IMAGING SYSTEMDigirad Corp.

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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