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FDA 510(k)

PX-100 PORTABLE X-RAY GENERATOR

K-Number: K921116 · 1992-10-05

ApplicantAcoma Medical Imaging, Inc.
Decision Date1992-10-05
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PX-100 PORTABLE X-RAY GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Acoma Medical Imaging, Inc.. It received FDA 510(k) clearance on 1992-10-05 under 510(k) number K921116. 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 PX-100 PORTABLE X-RAY GENERATOR?

PX-100 PORTABLE X-RAY GENERATOR is a medical device that received FDA 510(k) clearance on 1992-10-05. The listed applicant is Acoma Medical Imaging, Inc.. The 510(k) number is K921116.

When did PX-100 PORTABLE X-RAY GENERATOR receive FDA 510(k) clearance?

PX-100 PORTABLE X-RAY GENERATOR received FDA 510(k) clearance on 1992-10-05, under 510(k) number K921116.

Who is the listed applicant for PX-100 PORTABLE X-RAY GENERATOR?

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

What is the FDA product code for PX-100 PORTABLE X-RAY GENERATOR?

The FDA product code for PX-100 PORTABLE X-RAY GENERATOR is IZL.

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Other records listing Acoma Medical Imaging, Inc. as applicant

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K981227SYMPHONY 360 REMOTE CONTROL TABLEK981131PATHFINDER MOBILE C ARMK963851TILTING RADIOGRAPHIC TABLE (REMOTE)K944952ANGIOGRAPHIC SYSTEMK941004CTS SYSTEMK941017F/C/W TUBESTAND

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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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