510(k) K182234
K182234 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "Optima XR240amx". The FDA issued a decision of Substantially Equivalent on Sep 6, 2018. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Ge Medical Systems, LLC has 328 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 6, 2018
- Date Received
- Aug 17, 2018
- Clearance Type
- Special
- 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)