510(k) K181948
K181948 is an FDA 510(k) premarket notification submitted by Rapid Biomedical GmbH for the device "1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil". The FDA issued a decision of Substantially Equivalent on Nov 16, 2018. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Rapid Biomedical GmbH has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 16, 2018
- Date Received
- Jul 20, 2018
- 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)