The following data is part of a premarket notification filed by Biobot Surgical Pte Ltd with the FDA for Isr'obot Mri-us Fusion.
| Device ID | K161109 |
| 510k Number | K161109 |
| Device Name: | ISR'obot MRI-US Fusion |
| Classification | System, Image Processing, Radiological |
| Applicant | BIOBOT SURGICAL PTE LTD 2 WOODLANDS SPECTRUM 1, #03-10, WOODLANDS SECTOR 1 Singapore, SG 738068 |
| Contact | Lai Chee Liew |
| Correspondent | Lai Chee Liew BIOBOT SURGICAL PTE LTD 2 WOODLANDS SPECTRUM 1, #03-10, WOODLANDS SECTOR 1 Singapore, SG 738068 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-20 |
| Decision Date | 2016-10-06 |
| Summary: | summary |