510(k) K121800
K121800 is an FDA 510(k) premarket notification submitted by Pointnix Co., Ltd. for the device "POINT 500 HD POINT500C HD". The FDA issued a decision of Substantially Equivalent on Jan 24, 2013. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Pointnix Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 24, 2013
- Date Received
- Jun 19, 2012
- 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)