Ezsensor P Digital Intraoral Sensor
FDA 510(k) K121132 · Humanray Co,Ltd
510(k) numberK121132
Submission
- Device name
- Ezsensor P Digital Intraoral Sensor
- Applicant
- Humanray Co,Ltd
Houston, TX, US - Received
- April 13, 2012
- Decision date
- May 10, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Iray Imaging Technology (Haining) Limited
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Questions and answers
When was Ezsensor P Digital Intraoral Sensor cleared by the FDA?
Ezsensor P Digital Intraoral Sensor (K121132) received a 510(k) decision of Substantially Equivalent on May 10, 2012, 27 days after the submission was received.
What is the product code of K121132?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.