510(k) K190357
K190357 is an FDA 510(k) premarket notification submitted by Hdx Will Corp. for the device "Star-X, Intraoral X-ray System". The FDA issued a decision of Substantially Equivalent on Mar 15, 2019. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Hdx Will Corp. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 15, 2019
- Date Received
- Feb 15, 2019
- 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
- 510(k)