The following data is part of a premarket notification filed by Morpheus Imaging, Inc with the FDA for Heartscan Software.
| Device ID | K133937 |
| 510k Number | K133937 |
| Device Name: | HEARTSCAN SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | MORPHEUS IMAGING, INC 1700 4TH STREE MC 2522 BYERS HALL 214 San Francisco, CA 95158 |
| Contact | John Axerio-cilies |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-03-03 |
| Summary: | summary |