510(k) K181891
K181891 is an FDA 510(k) premarket notification submitted by Digimed Co., Ltd. for the device "Portable X-ray System (Model: MiniX-V, Mini X-S)". The FDA issued a decision of Substantially Equivalent on August 10, 2018. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Digimed Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2018
- Date Received
- July 13, 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