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FDA 510(k)

DIAMOND-5A/6A/8A

K-Number: K202156 · 2020-09-10

ApplicantDRGEM Corporation
Decision Date2020-09-10
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIAMOND-5A/6A/8A is the device name listed in this FDA 510(k) record. The listed applicant is DRGEM Corporation. It received FDA 510(k) clearance on 2020-09-10 under 510(k) number K202156. 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 DIAMOND-5A/6A/8A?

DIAMOND-5A/6A/8A is a medical device that received FDA 510(k) clearance on 2020-09-10. The listed applicant is DRGEM Corporation. The 510(k) number is K202156.

When did DIAMOND-5A/6A/8A receive FDA 510(k) clearance?

DIAMOND-5A/6A/8A received FDA 510(k) clearance on 2020-09-10, under 510(k) number K202156.

Who is the listed applicant for DIAMOND-5A/6A/8A?

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

What is the FDA product code for DIAMOND-5A/6A/8A?

The FDA product code for DIAMOND-5A/6A/8A is KPR.

Other records listing DRGEM Corporation as applicant

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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

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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