The following data is part of a premarket notification filed by Inter Medical Medizintechnik Gmbh with the FDA for Cx 250 C Plus With Gammaxp Software, Model 0121 0000.
| Device ID | K052473 |
| 510k Number | K052473 |
| Device Name: | CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 |
| Classification | Camera, Scintillation (gamma) |
| Applicant | INTER MEDICAL MEDIZINTECHNIK GMBH DAIMLERSTRASSE 34-36 Luebbecke, DE D-32312 |
| Contact | Hans Guenter Osiek |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-09 |
| Decision Date | 2005-10-28 |