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FDA 510(k)

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

K-Number: K231709 · 2023-07-12

ApplicantRadmedix, LLC
Decision Date2023-07-12
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 is the device name listed in this FDA 510(k) record. The listed applicant is Radmedix, LLC. It received FDA 510(k) clearance on 2023-07-12 under 510(k) number K231709. 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 AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4?

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 is a medical device that received FDA 510(k) clearance on 2023-07-12. The listed applicant is Radmedix, LLC. The 510(k) number is K231709.

When did AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 receive FDA 510(k) clearance?

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 received FDA 510(k) clearance on 2023-07-12, under 510(k) number K231709.

Who is the listed applicant for AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4?

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 AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4?

The FDA product code for AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 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.

K231995AcuityUDRK210919AcuityDReK201058Accuvue+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

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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