510(k) K172810
K172810 is an FDA 510(k) premarket notification submitted by Genoray Co., Ltd. for the device "PORT-X IV". The FDA issued a decision of Substantially Equivalent on March 7, 2018. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Genoray Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2018
- Date Received
- September 18, 2017
- 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