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FDA 510(k)

GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR

K-Number: K041922 · 2004-07-28

ApplicantGeneral Electric Co.
Decision Date2004-07-28
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR 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 2004-07-28 under 510(k) number K041922. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR?

GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR is a medical device that received FDA 510(k) clearance on 2004-07-28. The listed applicant is General Electric Co.. The 510(k) number is K041922.

When did GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR receive FDA 510(k) clearance?

GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR received FDA 510(k) clearance on 2004-07-28, under 510(k) number K041922.

Who is the listed applicant for GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR?

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 GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR?

The FDA product code for GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR is IZL.

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Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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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