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FDA 510(k)

MX MOBILE X-RAY SYSTEM

K-Number: K862452 · 1986-07-22

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1986-07-22
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MX MOBILE X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1986-07-22 under 510(k) number K862452. 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 MX MOBILE X-RAY SYSTEM?

MX MOBILE X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1986-07-22. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K862452.

When did MX MOBILE X-RAY SYSTEM receive FDA 510(k) clearance?

MX MOBILE X-RAY SYSTEM received FDA 510(k) clearance on 1986-07-22, under 510(k) number K862452.

Who is the listed applicant for MX MOBILE X-RAY SYSTEM?

The FDA 510(k) record lists Philips Medical Systems (Cleveland), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MX MOBILE X-RAY SYSTEM?

The FDA product code for MX MOBILE X-RAY SYSTEM is IZL.

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Other records listing Philips Medical Systems (Cleveland), Inc. as applicant

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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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