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FDA 510(k)

CORDLESS COMPACT MOBILE X-RAY SYSTEM

K-Number: K002685 · 2000-09-15

ApplicantMedison Radiology Systems, Inc.
Decision Date2000-09-15
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CORDLESS COMPACT MOBILE X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medison Radiology Systems, Inc.. It received FDA 510(k) clearance on 2000-09-15 under 510(k) number K002685. 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 CORDLESS COMPACT MOBILE X-RAY SYSTEM?

CORDLESS COMPACT MOBILE X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-09-15. The listed applicant is Medison Radiology Systems, Inc.. The 510(k) number is K002685.

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

CORDLESS COMPACT MOBILE X-RAY SYSTEM received FDA 510(k) clearance on 2000-09-15, under 510(k) number K002685.

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

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

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

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

Related Clinical Trials

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.

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Other records listing Medison Radiology Systems, Inc. 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.

K993896MCA-601, C-ARM MOBILE

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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