K052473 is an FDA 510(k) clearance for the CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by Inter Medical Medizintechnik GmbH (Luebbecke, DE). The FDA issued a Cleared decision on October 28, 2005, 49 days after receiving the submission on September 9, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K052473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2005 |
| Decision Date | October 28, 2005 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYX - Camera, Scintillation (gamma) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1100 |