510(k) K121132
K121132 is an FDA 510(k) premarket notification submitted by Humanray Co,Ltd for the device "EZSENSOR P DIGITAL INTRAORAL SENSOR". The FDA issued a decision of Substantially Equivalent on May 10, 2012. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Humanray Co,Ltd has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2012
- Date Received
- April 13, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type