Imaging Plate Scanner, i-Scan
FDA 510(k) K212080 · Guilin Woodpecker Medical Instrument Co., Ltd.
510(k) numberK212080
Submission
- Device name
- Imaging Plate Scanner, i-Scan
- Applicant
- Guilin Woodpecker Medical Instrument Co., Ltd.
Guilin, CN - Received
- July 2, 2021
- Decision date
- September 27, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Imaging Plate Scanner, i-Scan cleared by the FDA?
Imaging Plate Scanner, i-Scan (K212080) received a 510(k) decision of Substantially Equivalent on September 27, 2021, 87 days after the submission was received.
What is the product code of K212080?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.