510(k) K180561
K180561 is an FDA 510(k) premarket notification submitted by Denterprise International, Inc. for the device "MobileX Portable X-ray System". The FDA issued a decision of Substantially Equivalent on April 4, 2018. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Denterprise International, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2018
- Date Received
- March 5, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type