510(k) K132289
K132289 is an FDA 510(k) premarket notification submitted by Gemss Medical Systems Co., Ltd. for the device "GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 16, 2014. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), 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
- Jun 16, 2014
- Date Received
- Jul 23, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Fluoroscopic, Image-Intensified
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
- 510(k)