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FDA 510(k)

MOVIX DReamy

K-Number: K212515 · 2021-11-03

ApplicantStephanix
Decision Date2021-11-03
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOVIX DReamy is the device name listed in this FDA 510(k) record. The listed applicant is Stephanix. It received FDA 510(k) clearance on 2021-11-03 under 510(k) number K212515. 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 MOVIX DReamy?

MOVIX DReamy is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is Stephanix. The 510(k) number is K212515.

When did MOVIX DReamy receive FDA 510(k) clearance?

MOVIX DReamy received FDA 510(k) clearance on 2021-11-03, under 510(k) number K212515.

Who is the listed applicant for MOVIX DReamy?

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

What is the FDA product code for MOVIX DReamy?

The FDA product code for MOVIX DReamy is IZL.

Other records listing Stephanix 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.

K221335D²RS and D²RS 9090K213479D²RS and D²RS 9090

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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