K092018 is an FDA 510(k) clearance for the OMNIPRO INCLINE. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Iba Dosimetry GmbH (Bartlett, US). The FDA issued a Cleared decision on September 18, 2009, 74 days after receiving the submission on July 6, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K092018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2009 |
| Decision Date | September 18, 2009 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |