510(k) K161109
K161109 is an FDA 510(k) premarket notification submitted by Biobot Surgical Pte., Ltd. for the device "iSR'obot MRI-US Fusion". The FDA issued a decision of Substantially Equivalent on October 6, 2016. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Biobot Surgical Pte., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2016
- Date Received
- April 20, 2016
- Clearance Type
- Traditional
- 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