The following data is part of a premarket notification filed by Harmonus Inc. with the FDA for Probx Software.
| Device ID | K173312 |
| 510k Number | K173312 |
| Device Name: | ProBx Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Harmonus Inc. 110 Canal St 3rd Floor Lowell, MA 01852 |
| Contact | Nicole Mauro |
| Correspondent | Nandini Murthy Harmonus Inc. 110 Canal St 3rd Floor Lowell, MA 01852 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-19 |
| Decision Date | 2018-03-02 |
| Summary: | summary |