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FDA 510(k)

PHOENIX

K-Number: K212291 · 2021-09-14

ApplicantSedecal., Sa.
Decision Date2021-09-14
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHOENIX is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) number K212291. 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 PHOENIX?

PHOENIX is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is Sedecal., Sa.. The 510(k) number is K212291.

When did PHOENIX receive FDA 510(k) clearance?

PHOENIX received FDA 510(k) clearance on 2021-09-14, under 510(k) number K212291.

Who is the listed applicant for PHOENIX?

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

What is the FDA product code for PHOENIX?

The FDA product code for PHOENIX is IZL.

Other records listing Sedecal., Sa. 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.

K232185SM-IVK222951SM-VK221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.K203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic SystemsK202293Radiographic System Challenge XK192936Soltus 500

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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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