510(k) K140056
K140056 is an FDA 510(k) premarket notification submitted by Rayence Co., Ltd. for the device "DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A". The FDA issued a decision of Substantially Equivalent on May 13, 2014. 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. Rayence Co., Ltd. has 38 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2014
- Date Received
- Jan 10, 2014
- 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
- 510(k)