The following data is part of a premarket notification filed by Bracco Diagnostics Inc. with the FDA for Heartsee Cardiac P.e.t. Processing Software.
| Device ID | K181343 |
| 510k Number | K181343 |
| Device Name: | HeartSee Cardiac P.E.T. Processing Software |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Bracco Diagnostics Inc. 259 Prospect Plains Road, Building H Monroe Township, NE 08831 |
| Contact | Patrice Marchildon |
| Correspondent | Patrice Marchildon Bracco Diagnostics Inc. 259 Prospect Plains Road, Building H Monroe Township, NJ 08831 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-21 |
| Decision Date | 2018-06-12 |
| Summary: | summary |