The following data is part of a premarket notification filed by Focal Healtcare Inc. with the FDA for Fusion Bx.
| Device ID | K153166 |
| 510k Number | K153166 |
| Device Name: | Fusion Bx |
| Classification | System, Image Processing, Radiological |
| Applicant | FOCAL HEALTCARE INC. 10 MORROW AVE., UNIT 101 Toronto, CA M6r 2j1 |
| Contact | Maham Ansari |
| Correspondent | Georg M Bauer TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-11-02 |
| Decision Date | 2016-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26280558580010 | K153166 | 000 |
| 00628055858003 | K153166 | 000 |