510(k) K202369
K202369 is an FDA 510(k) premarket notification submitted by Rolence Enterprise, Inc. for the device "RXS 1000". The FDA issued a decision of Substantially Equivalent on Sep 15, 2021. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Rolence Enterprise, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 15, 2021
- Date Received
- Aug 19, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type
- 510(k)