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FDA 510(k)

OSTEO-RAY 100

K-Number: K953404 · 1995-11-30

ApplicantMicro Focus Imaging, Inc.
Decision Date1995-11-30
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OSTEO-RAY 100 is the device name listed in this FDA 510(k) record. The listed applicant is Micro Focus Imaging, Inc.. It received FDA 510(k) clearance on 1995-11-30 under 510(k) number K953404. 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 OSTEO-RAY 100?

OSTEO-RAY 100 is a medical device that received FDA 510(k) clearance on 1995-11-30. The listed applicant is Micro Focus Imaging, Inc.. The 510(k) number is K953404.

When did OSTEO-RAY 100 receive FDA 510(k) clearance?

OSTEO-RAY 100 received FDA 510(k) clearance on 1995-11-30, under 510(k) number K953404.

Who is the listed applicant for OSTEO-RAY 100?

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

What is the FDA product code for OSTEO-RAY 100?

The FDA product code for OSTEO-RAY 100 is IZL.

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Other records listing Micro Focus Imaging, 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.

K953292CP 100/30K926434SIS-300(N)-DIA SCANK852634MICRO-FOCUS 50 CABINET X-RAY

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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