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FDA 510(k)

Optical Topography System ETG-4100

K-Number: K172492 · 2018-08-17

ApplicantHitachi Healthcare Americas
Decision Date2018-08-17
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Optical Topography System ETG-4100 is a medical device manufactured by Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2018-08-17 under approval number K172492. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optical Topography System ETG-4100?

Optical Topography System ETG-4100 is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Hitachi Healthcare Americas. The 510(k) number is K172492.

When was Optical Topography System ETG-4100 approved by the FDA?

Optical Topography System ETG-4100 received FDA 510(k) clearance on 2018-08-17, under approval number K172492.

What company makes Optical Topography System ETG-4100?

Optical Topography System ETG-4100 is manufactured by Hitachi Healthcare Americas.

What is the FDA product code for Optical Topography System ETG-4100?

The FDA product code for Optical Topography System ETG-4100 is DQA.

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Related Devices (Code: DQA)

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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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