The following data is part of a premarket notification filed by Hermes Medical Solutions, Ab with the FDA for Hermes Medical Imaging Suite V5.6.
| Device ID | K153056 |
| 510k Number | K153056 |
| Device Name: | Hermes Medical Imaging Suite V5.6 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | HERMES MEDICAL SOLUTIONS, AB SKEPPSBRON 44 Stockholm, SE 11130 |
| Contact | Joakim Arwidson |
| Correspondent | Joakim Arwidson HERMES MEDICAL SOLUTIONS, AB SKEPPSBRON 44 Stockholm, SE 11130 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-21 |
| Decision Date | 2016-06-01 |
| Summary: | summary |