FDA 510(k)

CuattroDR

K-Number: K161937 · 2016-10-06

Decision Date2016-10-06

Product CodeKPR

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CuattroDR is the device name listed in this FDA 510(k) record. The listed applicant is Cuattro, LLC. It received FDA 510(k) clearance on 2016-10-06 under 510(k) number K161937. 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 CuattroDR?

CuattroDR is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Cuattro, LLC. The 510(k) number is K161937.

When did CuattroDR receive FDA 510(k) clearance?

CuattroDR received FDA 510(k) clearance on 2016-10-06, under 510(k) number K161937.

Who is the listed applicant for CuattroDR?

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

What is the FDA product code for CuattroDR?

The FDA product code for CuattroDR is KPR.

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 Health K252000uDR 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.