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FDA 510(k)

DIGITAL FLUOROGRAPHIC X-RAY SYSTEM

K-Number: K802953 · 1981-01-09

ApplicantGeneral Electric Co.
Decision Date1981-01-09
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL FLUOROGRAPHIC X-RAY 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 1981-01-09 under 510(k) number K802953. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL FLUOROGRAPHIC X-RAY SYSTEM?

DIGITAL FLUOROGRAPHIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1981-01-09. The listed applicant is General Electric Co.. The 510(k) number is K802953.

When did DIGITAL FLUOROGRAPHIC X-RAY SYSTEM receive FDA 510(k) clearance?

DIGITAL FLUOROGRAPHIC X-RAY SYSTEM received FDA 510(k) clearance on 1981-01-09, under 510(k) number K802953.

Who is the listed applicant for DIGITAL FLUOROGRAPHIC X-RAY 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 DIGITAL FLUOROGRAPHIC X-RAY SYSTEM?

The FDA product code for DIGITAL FLUOROGRAPHIC X-RAY SYSTEM is JAA.

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Other records listing General Electric Co. as applicant

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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: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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