510(k) K222080
K222080 is an FDA 510(k) premarket notification submitted by Sg Healthcare Co, Ltd. for the device "Garion Image-Intensified Fluoroscopic X-Ray System, Mobile". The FDA issued a decision of Substantially Equivalent on Oct 6, 2022. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Sg Healthcare Co, Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 6, 2022
- Date Received
- Jul 15, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interventional Fluoroscopic X-Ray System
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
- 510(k)
Interventional fluoroscopy