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FDA 510(k)

Halifax Imaging Kit

K-Number: K182880 · 2018-10-31

ApplicantHalifax Biomedical, Inc.
Decision Date2018-10-31
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Halifax Imaging Kit is the device name listed in this FDA 510(k) record. The listed applicant is Halifax Biomedical, Inc.. It received FDA 510(k) clearance on 2018-10-31 under 510(k) number K182880. 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 Halifax Imaging Kit?

Halifax Imaging Kit is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Halifax Biomedical, Inc.. The 510(k) number is K182880.

When did Halifax Imaging Kit receive FDA 510(k) clearance?

Halifax Imaging Kit received FDA 510(k) clearance on 2018-10-31, under 510(k) number K182880.

Who is the listed applicant for Halifax Imaging Kit?

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

What is the FDA product code for Halifax Imaging Kit?

The FDA product code for Halifax Imaging Kit 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 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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