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FDA 510(k)

Imaging Plate Scanner, i-Scan

K-Number: K212080 · 2021-09-27

ApplicantGuilin Woodpecker Medical Instrument Co., Ltd.
Decision Date2021-09-27
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Imaging Plate Scanner, i-Scan is a medical device manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-09-27 under approval number K212080. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Imaging Plate Scanner, i-Scan?

Imaging Plate Scanner, i-Scan is a medical device that received FDA 510(k) clearance on 2021-09-27. It is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K212080.

When was Imaging Plate Scanner, i-Scan approved by the FDA?

Imaging Plate Scanner, i-Scan received FDA 510(k) clearance on 2021-09-27, under approval number K212080.

What company makes Imaging Plate Scanner, i-Scan?

Imaging Plate Scanner, i-Scan is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd..

What is the FDA product code for Imaging Plate Scanner, i-Scan?

The FDA product code for Imaging Plate Scanner, i-Scan is MUH.

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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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