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FDA 510(k)

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard

K-Number: K193360 · 2020-01-02

ApplicantRadmedix, LLC
Decision Date2020-01-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is the device name listed in this FDA 510(k) record. The listed applicant is Radmedix, LLC. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K193360. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard?

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Radmedix, LLC. The 510(k) number is K193360.

When did Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard receive FDA 510(k) clearance?

Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard received FDA 510(k) clearance on 2020-01-02, under 510(k) number K193360.

Who is the listed applicant for Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard?

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 Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard?

The FDA product code for Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard is KPR.

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+K200726AcuityPDR

Related Devices (Code: KPR)

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.

K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream HealthK252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.K250788Definium Tempo SelectGe Hualun Medical Systems 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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