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FDA 510(k)

MAXI CAMERA/D

K-Number: K811676 · 1981-07-02

ApplicantGeneral Electric Co.
Decision Date1981-07-02
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAXI CAMERA/D 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 1981-07-02 under 510(k) number K811676. 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 MAXI CAMERA/D?

MAXI CAMERA/D is a medical device that received FDA 510(k) clearance on 1981-07-02. The listed applicant is General Electric Co.. The 510(k) number is K811676.

When did MAXI CAMERA/D receive FDA 510(k) clearance?

MAXI CAMERA/D received FDA 510(k) clearance on 1981-07-02, under 510(k) number K811676.

Who is the listed applicant for MAXI CAMERA/D?

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 MAXI CAMERA/D?

The FDA product code for MAXI CAMERA/D is IYX.

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Other records listing General Electric Co. as applicant

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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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