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FDA 510(k)

AcuityDRe

K-Number: K210919 · 2021-04-30

ApplicantRadmedix, LLC
Decision Date2021-04-30
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AcuityDRe is the device name listed in this FDA 510(k) record. The listed applicant is Radmedix, LLC. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K210919. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AcuityDRe?

AcuityDRe is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Radmedix, LLC. The 510(k) number is K210919.

When did AcuityDRe receive FDA 510(k) clearance?

AcuityDRe received FDA 510(k) clearance on 2021-04-30, under 510(k) number K210919.

Who is the listed applicant for AcuityDRe?

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 AcuityDRe?

The FDA product code for AcuityDRe is MQB.

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 1717G4K201058Accuvue+K200726AcuityPDRK193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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