K073704 is an FDA 510(k) clearance for the I-DIXEL. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on February 21, 2008, 52 days after receiving the submission on December 31, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K073704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2007 |
| Decision Date | February 21, 2008 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |