Hand Diagnostic Radiography Imaging System

System, X-ray, Stationary

NanoRay Biotech Co., Ltd

The following data is part of a premarket notification filed by Nanoray Biotech Co., Ltd with the FDA for Hand Diagnostic Radiography Imaging System.

Pre-market Notification Details

Device IDK220271
510k NumberK220271
Device Name:Hand Diagnostic Radiography Imaging System
ClassificationSystem, X-ray, Stationary
Applicant NanoRay Biotech Co., Ltd 7F., No.91, Xinhu 1st Rd., Neihu Dist. Taipei City,  TW 114
ContactAlice Chen
CorrespondentAlice Chen
NanoRay Biotech Co., Ltd 7F., No.91, Xinhu 1st Rd., Neihu Dist. Taipei City,  TW 114
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-31
Decision Date2022-04-29

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