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FDA 510(k)

MODEL MBA-130 MOBILE X-RAY SYSTEM

K-Number: K862118 · 1986-06-16

ApplicantElscint, Inc.
Decision Date1986-06-16
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL MBA-130 MOBILE X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1986-06-16 under 510(k) number K862118. 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 MODEL MBA-130 MOBILE X-RAY SYSTEM?

MODEL MBA-130 MOBILE X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is Elscint, Inc.. The 510(k) number is K862118.

When did MODEL MBA-130 MOBILE X-RAY SYSTEM receive FDA 510(k) clearance?

MODEL MBA-130 MOBILE X-RAY SYSTEM received FDA 510(k) clearance on 1986-06-16, under 510(k) number K862118.

Who is the listed applicant for MODEL MBA-130 MOBILE X-RAY SYSTEM?

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

What is the FDA product code for MODEL MBA-130 MOBILE X-RAY SYSTEM?

The FDA product code for MODEL MBA-130 MOBILE X-RAY SYSTEM is IZL.

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Other records listing Elscint, Inc. as applicant

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K983313ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORYK982060VOLUMAX CT IMAGING SYSTEMK974344CT SCOPEK980306GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EPK974614GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102K9725922T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)

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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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