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FDA 510(k)

GENERAL ELECTRIC RADVIEW MARK I SYSTEM

K-Number: K800564 · 1980-05-02

ApplicantGeneral Electric Co.
Decision Date1980-05-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GENERAL ELECTRIC RADVIEW MARK I SYSTEM 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 1980-05-02 under 510(k) number K800564. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERAL ELECTRIC RADVIEW MARK I SYSTEM?

GENERAL ELECTRIC RADVIEW MARK I SYSTEM is a medical device that received FDA 510(k) clearance on 1980-05-02. The listed applicant is General Electric Co.. The 510(k) number is K800564.

When did GENERAL ELECTRIC RADVIEW MARK I SYSTEM receive FDA 510(k) clearance?

GENERAL ELECTRIC RADVIEW MARK I SYSTEM received FDA 510(k) clearance on 1980-05-02, under 510(k) number K800564.

Who is the listed applicant for GENERAL ELECTRIC RADVIEW MARK I SYSTEM?

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 GENERAL ELECTRIC RADVIEW MARK I SYSTEM?

The FDA product code for GENERAL ELECTRIC RADVIEW MARK I SYSTEM is KPR.

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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: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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