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FDA 510(k)

MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT

K-Number: K945707 · 1995-01-19

ApplicantMinxray, Inc.
Decision Date1995-01-19
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 1995-01-19 under 510(k) number K945707. 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 MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT?

MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT is a medical device that received FDA 510(k) clearance on 1995-01-19. The listed applicant is Minxray, Inc.. The 510(k) number is K945707.

When did MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT receive FDA 510(k) clearance?

MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT received FDA 510(k) clearance on 1995-01-19, under 510(k) number K945707.

Who is the listed applicant for MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT?

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

What is the FDA product code for MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT?

The FDA product code for MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT is IZL.

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Other records listing Minxray, Inc. as applicant

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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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