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FDA 510(k)

INNOVISION-P5

K-Number: K250750 · 2025-07-18

ApplicantDk Medical Systems Co., Ltd.
Decision Date2025-07-18
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INNOVISION-P5 is the device name listed in this FDA 510(k) record. The listed applicant is Dk Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K250750. 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 INNOVISION-P5?

INNOVISION-P5 is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Dk Medical Systems Co., Ltd.. The 510(k) number is K250750.

When did INNOVISION-P5 receive FDA 510(k) clearance?

INNOVISION-P5 received FDA 510(k) clearance on 2025-07-18, under 510(k) number K250750.

Who is the listed applicant for INNOVISION-P5?

The FDA 510(k) record lists Dk Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVISION-P5?

The FDA product code for INNOVISION-P5 is IZL.

Other records listing Dk Medical Systems Co., Ltd. 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.

K253446AeroDR TX c02K250790INNOVISION-DXII

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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