K182234 is an FDA 510(k) clearance for the Optima XR240amx. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on September 6, 2018, 20 days after receiving the submission on August 17, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K182234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2018 |
| Decision Date | September 06, 2018 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL — System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |