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FDA 510(k)

NanoZoomer S360MD Slide scanner system

K-Number: K213883 · 2022-09-27

ApplicantHamamatsu Photonics K.K.
Decision Date2022-09-27
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

NanoZoomer S360MD Slide scanner system is a medical device manufactured by Hamamatsu Photonics K.K.. It received FDA 510(k) clearance on 2022-09-27 under approval number K213883. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NanoZoomer S360MD Slide scanner system?

NanoZoomer S360MD Slide scanner system is a medical device that received FDA 510(k) clearance on 2022-09-27. It is manufactured by Hamamatsu Photonics K.K.. The 510(k) number is K213883.

When was NanoZoomer S360MD Slide scanner system approved by the FDA?

NanoZoomer S360MD Slide scanner system received FDA 510(k) clearance on 2022-09-27, under approval number K213883.

What company makes NanoZoomer S360MD Slide scanner system?

NanoZoomer S360MD Slide scanner system is manufactured by Hamamatsu Photonics K.K..

What is the FDA product code for NanoZoomer S360MD Slide scanner system?

The FDA product code for NanoZoomer S360MD Slide scanner system is PSY.

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Other Devices by Hamamatsu Photonics K.K.

K162117NIRO-200NX DP K233027NanoZoomer S360MD Slide scanner system

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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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