510(k) K193369
K193369 is an FDA 510(k) premarket notification submitted by Infinitt Healthcare Co., Ltd. for the device "Xelis Dental 2.0". The FDA issued a decision of Substantially Equivalent on April 14, 2020. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Infinitt Healthcare Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2020
- Date Received
- December 5, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type