The following data is part of a premarket notification filed by Hermes Medical Solutions, Ab with the FDA for Hermes Medical Imaging Suite V5.3.
| Device ID | K131233 |
| 510k Number | K131233 |
| Device Name: | HERMES MEDICAL IMAGING SUITE V5.3 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | HERMES MEDICAL SOLUTIONS, AB SKEPPSBRON 44 Stockholm, SE 111 30 |
| Contact | Joakim Arwidson |
| Correspondent | Joakim Arwidson HERMES MEDICAL SOLUTIONS, AB SKEPPSBRON 44 Stockholm, SE 111 30 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2013-07-16 |
| Summary: | summary |