510(k) K182626
K182626 is an FDA 510(k) premarket notification submitted by Ge Hualun Medical Systems Co. , Ltd. for the device "OEC One". The FDA issued a decision of Substantially Equivalent on November 16, 2018. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Ge Hualun Medical Systems Co. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2018
- Date Received
- September 24, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
Fluoroscopy of the human body.