FDA 510(k)

Hand Diagnostic Radiography Imaging System

Número K: K220271 · 2022-04-29

Data da decisão2022-04-29

Código do produtoKPR

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hand Diagnostic Radiography Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Nanoray Biotech Co., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K220271. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hand Diagnostic Radiography Imaging System?

Hand Diagnostic Radiography Imaging System is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Nanoray Biotech Co., Ltd.. The 510(k) number is K220271.

When did Hand Diagnostic Radiography Imaging System receive FDA 510(k) clearance?

Hand Diagnostic Radiography Imaging System received FDA 510(k) clearance on 2022-04-29, under 510(k) number K220271.

Who is the listed applicant for Hand Diagnostic Radiography Imaging System?

The FDA 510(k) record lists Nanoray Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hand Diagnostic Radiography Imaging System?

The FDA product code for Hand Diagnostic Radiography Imaging System is KPR.

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