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FDA 510(k)

MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM

K-Number: K893637 · 1989-07-20

ApplicantShimadzu Medical Systems
Decision Date1989-07-20
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Medical Systems. It received FDA 510(k) clearance on 1989-07-20 under 510(k) number K893637. 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 MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM?

MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-07-20. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K893637.

When did MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM receive FDA 510(k) clearance?

MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM received FDA 510(k) clearance on 1989-07-20, under 510(k) number K893637.

Who is the listed applicant for MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM?

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

What is the FDA product code for MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM?

The FDA product code for MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM is IZL.

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Other records listing Shimadzu Medical Systems 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.

K082224DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONICK071291ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100K071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PROK071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO

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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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