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FDA 510(k)

Micro C Medical Imaging System, M01

K-Number: K212654 · 2022-02-04

ApplicantOxos Medical, Inc.
Decision Date2022-02-04
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Micro C Medical Imaging System, M01 is the device name listed in this FDA 510(k) record. The listed applicant is Oxos Medical, Inc.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K212654. 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 Micro C Medical Imaging System, M01?

Micro C Medical Imaging System, M01 is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Oxos Medical, Inc.. The 510(k) number is K212654.

When did Micro C Medical Imaging System, M01 receive FDA 510(k) clearance?

Micro C Medical Imaging System, M01 received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212654.

Who is the listed applicant for Micro C Medical Imaging System, M01?

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

What is the FDA product code for Micro C Medical Imaging System, M01?

The FDA product code for Micro C Medical Imaging System, M01 is IZL.

Other records listing Oxos Medical, 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.

K252068MC2 Portable X-ray SystemK241567MC2 Portable X-ray SystemK211473Micro C Medical Imaging System, M01K203658Micro C Medical Imaging System, M01

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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