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FDA 510(k)

AcuityUDR

K-Number: K231995 · 2023-10-25

ApplicantRadmedix, LLC
Decision Date2023-10-25
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AcuityUDR is a medical device manufactured by Radmedix, LLC. It received FDA 510(k) clearance on 2023-10-25 under approval number K231995. 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 AcuityUDR?

AcuityUDR is a medical device that received FDA 510(k) clearance on 2023-10-25. It is manufactured by Radmedix, LLC. The 510(k) number is K231995.

When was AcuityUDR approved by the FDA?

AcuityUDR received FDA 510(k) clearance on 2023-10-25, under approval number K231995.

What company makes AcuityUDR?

AcuityUDR is manufactured by Radmedix, LLC.

What is the FDA product code for AcuityUDR?

The FDA product code for AcuityUDR is KPR.

Other Devices by Radmedix, LLC

K201058Accuvue+ K200726AcuityPDR K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard K210919AcuityDRe K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

Related Devices (Code: KPR)

K163203Carestream DRX-EvolutionCarestream Health, Inc. K163115GC70Samsung Electronics Co., Ltd. K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd. K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc. K161937CuattroDRCuattro, LLC K162224ArtPix Mobile EZ2GOCmt Medical Technologies, 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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