The following data is part of a premarket notification filed by Focal Healthcare Inc. with the FDA for Fusion Bx 2.0.
| Device ID | K181290 |
| 510k Number | K181290 |
| Device Name: | Fusion Bx 2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Focal Healthcare Inc. 10 Morrow Ave., Unit 101 Toronto, CA M6r 2j1 |
| Contact | Karen Zhou |
| Correspondent | Karen Zhou Focal Healthcare Inc. 10 Morrow Ave., Unit 101 Toronto, CA M6r 2j1 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-16 |
| Decision Date | 2018-06-15 |
| Summary: | summary |