Cleared Traditional

Imaging Plate Scanner, i-Scan

K212080 · Guilin Woodpecker Medical Instrument Co., Ltd. · Radiology
Sep 2021
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K212080 is an FDA 510(k) clearance for the Imaging Plate Scanner, i-Scan, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on September 27, 2021, 87 days after receiving the submission on July 2, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K212080 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2021
Decision Date September 27, 2021
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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