510(k) K160065
K160065 is an FDA 510(k) premarket notification submitted by Gemss Medical Systems Co., Ltd. for the device "GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System". The FDA issued a decision of Substantially Equivalent on May 20, 2016. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Gemss Medical Systems Co., Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2016
- Date Received
- Jan 13, 2016
- 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
- 510(k)
Fluoroscopy of the human body.