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FDA 510(k)

FLUORICON 500 IMAGE INTENSIFIERS

K-Number: K770094 · 1977-01-21

ApplicantGeneral Electric Co.
Decision Date1977-01-21
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLUORICON 500 IMAGE INTENSIFIERS 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 1977-01-21 under 510(k) number K770094. The device is classified under product code EAM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORICON 500 IMAGE INTENSIFIERS?

FLUORICON 500 IMAGE INTENSIFIERS is a medical device that received FDA 510(k) clearance on 1977-01-21. The listed applicant is General Electric Co.. The 510(k) number is K770094.

When did FLUORICON 500 IMAGE INTENSIFIERS receive FDA 510(k) clearance?

FLUORICON 500 IMAGE INTENSIFIERS received FDA 510(k) clearance on 1977-01-21, under 510(k) number K770094.

Who is the listed applicant for FLUORICON 500 IMAGE INTENSIFIERS?

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 FLUORICON 500 IMAGE INTENSIFIERS?

The FDA product code for FLUORICON 500 IMAGE INTENSIFIERS is EAM.

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Other records listing General Electric Co. 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.

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: EAM)

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.

K974423ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAILSterling Diagnostic Imaging, Inc.K963913MD100 & MM150Konica Medical Corp.K954161JPI INTENSIFYING SCREENJpi Healthcare Co, Ltd.K943822FUJI UM MAMMO SERIES INTENSIFY SCREENS:Fujifilm Medical System U.S.A., Inc.K943823FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12Fujifilm Medical System U.S.A., Inc.K943821KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPECFujifilm Medical System U.S.A., Inc.

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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