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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 the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-09-27 under 510(k) 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. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K212080.

When did Imaging Plate Scanner, i-Scan receive FDA 510(k) clearance?

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

Who is the listed applicant for Imaging Plate Scanner, i-Scan?

The FDA 510(k) record lists Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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