510(k) K182207
K182207 is an FDA 510(k) premarket notification submitted by Minxray, Inc. for the device "TR90BH". The FDA issued a decision of Substantially Equivalent on Dec 14, 2018. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Minxray, Inc. has 17 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 14, 2018
- Date Received
- Aug 15, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type
- 510(k)