The following data is part of a premarket notification filed by Mie America, Inc. with the FDA for Mie - Gamma Camera Systems.
| Device ID | K053086 |
| 510k Number | K053086 |
| Device Name: | MIE - GAMMA CAMERA SYSTEMS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | MIE AMERICA, INC. 420 BENNETT RD. Elk Grove Village, IL 60007 |
| Contact | Kay Warren |
| Correspondent | Kay Warren MIE AMERICA, INC. 420 BENNETT RD. Elk Grove Village, IL 60007 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-02 |
| Decision Date | 2006-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260484140074 | K053086 | 000 |
| 04260484140043 | K053086 | 000 |