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FDA 510(k)

Hand Diagnostic Radiography Imaging System

K-Number: K220271 · 2022-04-29

ApplicantNanoray Biotech Co., Ltd.
Decision Date2022-04-29
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hand Diagnostic Radiography Imaging System is a medical device manufactured by Nanoray Biotech Co., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under approval number K220271. 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 Hand Diagnostic Radiography Imaging System?

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

When was Hand Diagnostic Radiography Imaging System approved by the FDA?

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

What company makes Hand Diagnostic Radiography Imaging System?

Hand Diagnostic Radiography Imaging System is manufactured by Nanoray Biotech Co., Ltd..

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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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41385025 AI medical device post-market surveillance regulations: consensus recommendations by the European Society of Radiology. Insights into imaging (2025) PMID: 41378019 Advancing circular economy practices in radiography: a narrative review of sustainable medical imaging. Translational cancer research (2025)

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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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