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FDA 510(k)

GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80

K-Number: K802548 · 1980-12-02

ApplicantGeneral Electric Co.
Decision Date1980-12-02
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 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 1980-12-02 under 510(k) number K802548. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80?

GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 is a medical device that received FDA 510(k) clearance on 1980-12-02. The listed applicant is General Electric Co.. The 510(k) number is K802548.

When did GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 receive FDA 510(k) clearance?

GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 received FDA 510(k) clearance on 1980-12-02, under 510(k) number K802548.

Who is the listed applicant for GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80?

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 GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80?

The FDA product code for GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 is IZO.

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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: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, 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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