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FDA 510(k)

AcuityPDR

K-Number: K200726 · 2020-04-13

ApplicantRadmedix, LLC
Decision Date2020-04-13
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AcuityPDR is the device name listed in this FDA 510(k) record. The listed applicant is Radmedix, LLC. It received FDA 510(k) clearance on 2020-04-13 under 510(k) number K200726. 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 AcuityPDR?

AcuityPDR is a medical device that received FDA 510(k) clearance on 2020-04-13. The listed applicant is Radmedix, LLC. The 510(k) number is K200726.

When did AcuityPDR receive FDA 510(k) clearance?

AcuityPDR received FDA 510(k) clearance on 2020-04-13, under 510(k) number K200726.

Who is the listed applicant for AcuityPDR?

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

What is the FDA product code for AcuityPDR?

The FDA product code for AcuityPDR is IZL.

Other records listing Radmedix, LLC 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.

K231995AcuityUDRK231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4K210919AcuityDReK201058Accuvue+K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard

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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