The following data is part of a premarket notification filed by Mie Gmbh with the FDA for Mie Scintron Gamma Camera Systems.
| Device ID | K101768 |
| 510k Number | K101768 |
| Device Name: | MIE SCINTRON GAMMA CAMERA SYSTEMS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | MIE GMBH HAUPTSTR. 112 Seth, DE D-23845 |
| Contact | Thomas Kuhl |
| Correspondent | Thomas Kuhl MIE GMBH HAUPTSTR. 112 Seth, DE D-23845 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-23 |
| Decision Date | 2010-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260484140036 | K101768 | 000 |