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FDA 510(k)

AMX5 AND AMX5D MOBILE X-RAY SYSTEMS

K-Number: K042866 · 2004-11-02

ApplicantGe Healthcare Technologies
Decision Date2004-11-02
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMX5 AND AMX5D MOBILE X-RAY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Technologies. It received FDA 510(k) clearance on 2004-11-02 under 510(k) number K042866. 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 AMX5 AND AMX5D MOBILE X-RAY SYSTEMS?

AMX5 AND AMX5D MOBILE X-RAY SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-11-02. The listed applicant is Ge Healthcare Technologies. The 510(k) number is K042866.

When did AMX5 AND AMX5D MOBILE X-RAY SYSTEMS receive FDA 510(k) clearance?

AMX5 AND AMX5D MOBILE X-RAY SYSTEMS received FDA 510(k) clearance on 2004-11-02, under 510(k) number K042866.

Who is the listed applicant for AMX5 AND AMX5D MOBILE X-RAY SYSTEMS?

The FDA 510(k) record lists Ge Healthcare Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMX5 AND AMX5D MOBILE X-RAY SYSTEMS?

The FDA product code for AMX5 AND AMX5D MOBILE X-RAY SYSTEMS is IZL.

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Other records listing Ge Healthcare Technologies 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.

K051734GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955

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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