510(k) K181290
K181290 is an FDA 510(k) premarket notification submitted by Focal Healthcare, Inc. for the device "Fusion Bx 2.0". The FDA issued a decision of Substantially Equivalent on Jun 15, 2018. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 15, 2018
- Date Received
- May 16, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)