The following data is part of a premarket notification filed by Halifax Biomedical, Inc. with the FDA for Model-based Rsa Software.
| Device ID | K133966 |
| 510k Number | K133966 |
| Device Name: | MODEL-BASED RSA SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | HALIFAX BIOMEDICAL, INC. 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm HALIFAX BIOMEDICAL, INC. 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-24 |
| Decision Date | 2014-03-06 |
| Summary: | summary |