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FDA 510(k)

SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION

K-Number: K080701 · 2008-05-14

ApplicantShimadzu Corp.
Decision Date2008-05-14
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 2008-05-14 under 510(k) number K080701. 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 SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION?

SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION is a medical device that received FDA 510(k) clearance on 2008-05-14. The listed applicant is Shimadzu Corp.. The 510(k) number is K080701.

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

SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION received FDA 510(k) clearance on 2008-05-14, under 510(k) number K080701.

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

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 SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION?

The FDA product code for SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION 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 EVOLUTIONK072006DAR-9400FK071717GE OEC ALTITUDE

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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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