The following data is part of a premarket notification filed by Hermes Medical Solutions Ab with the FDA for Hermes Medical Imaging Suite V5.7.
| Device ID | K171681 |
| 510k Number | K171681 |
| Device Name: | Hermes Medical Imaging Suite V5.7 |
| 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 | 2017-06-06 |
| Decision Date | 2017-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859873006059 | K171681 | 000 |
| 00859873006158 | K171681 | 000 |