510(k) K190668
K190668 is an FDA 510(k) premarket notification submitted by Qfix for the device "Encompass 15 Channel Head Coil, 3T". The FDA issued a decision of Substantially Equivalent on Sep 9, 2019. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Qfix has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 9, 2019
- Date Received
- Mar 15, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coil, Magnetic Resonance, Specialty
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)