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FDA 510(k)

MOBILE X-RAY SYSTEM

K-Number: K955036 · 1995-12-22

ApplicantShimadzu Corp.
Decision Date1995-12-22
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBILE X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K955036. 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 MOBILE X-RAY SYSTEM?

MOBILE X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Shimadzu Corp.. The 510(k) number is K955036.

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

MOBILE X-RAY SYSTEM received FDA 510(k) clearance on 1995-12-22, under 510(k) number K955036.

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

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

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

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

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Other records listing Shimadzu Corp. 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.

K101039SHIMADZU COLLIMATOR R-300K101036SHIMADZU COLLIMATOR R-20JK090578SHIMADZU COLLIMATOR R-30HK090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONK080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONK072006DAR-9400F

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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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