510(k) K172928
K172928 is an FDA 510(k) premarket notification submitted by Rolence Enterprise, Inc. for the device "Portable X-ray System". The FDA issued a decision of Substantially Equivalent on Mar 16, 2018. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Rolence Enterprise, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 16, 2018
- Date Received
- Sep 25, 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
- 510(k)