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FDA 510(k)

Diagnostic Imaging Color LCD Monitor

K-Number: K161057 · 2016-05-13

ApplicantNec Display Solutions , Ltd.
Decision Date2016-05-13
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Diagnostic Imaging Color LCD Monitor is a medical device manufactured by Nec Display Solutions , Ltd.. It received FDA 510(k) clearance on 2016-05-13 under approval number K161057. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diagnostic Imaging Color LCD Monitor?

Diagnostic Imaging Color LCD Monitor is a medical device that received FDA 510(k) clearance on 2016-05-13. It is manufactured by Nec Display Solutions , Ltd.. The 510(k) number is K161057.

When was Diagnostic Imaging Color LCD Monitor approved by the FDA?

Diagnostic Imaging Color LCD Monitor received FDA 510(k) clearance on 2016-05-13, under approval number K161057.

What company makes Diagnostic Imaging Color LCD Monitor?

Diagnostic Imaging Color LCD Monitor is manufactured by Nec Display Solutions , Ltd..

What is the FDA product code for Diagnostic Imaging Color LCD Monitor?

The FDA product code for Diagnostic Imaging Color LCD Monitor is PGY.

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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: 41271017 Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration. Biomedical journal (2025)

Related Devices (Code: PGY)

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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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