The following data is part of a premarket notification filed by Mirada Solutions Ltd. with the FDA for Fusion 7d.
| Device ID | K020546 |
| 510k Number | K020546 |
| Device Name: | FUSION 7D |
| Classification | System, Image Processing, Radiological |
| Applicant | MIRADA SOLUTIONS LTD. CTI MOLECULAR IMAGING, INC. 810 INNOVATION DRIVE Knoxville, TN 37932 |
| Contact | Roger W Barnes |
| Correspondent | Roger W Barnes MIRADA SOLUTIONS LTD. CTI MOLECULAR IMAGING, INC. 810 INNOVATION DRIVE Knoxville, TN 37932 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-04-26 |
| Summary: | summary |