The following data is part of a premarket notification filed by Segami Corporation with the FDA for Mirage, Release 5.5.
| Device ID | K043441 |
| 510k Number | K043441 |
| Device Name: | MIRAGE, RELEASE 5.5 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SEGAMI CORPORATION 8325 GUILFORD RD., SUITE B Columbia, MD 21046 |
| Contact | Philippe Briandet |
| Correspondent | Philippe Briandet SEGAMI CORPORATION 8325 GUILFORD RD., SUITE B Columbia, MD 21046 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-14 |
| Decision Date | 2005-01-13 |