K131616 is an FDA 510(k) clearance for the EZ3D-I, E3. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Ewoosoft Co., Ltd. (Houston, US). The FDA issued a Cleared decision on August 29, 2013, 87 days after receiving the submission on June 3, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K131616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2013 |
| Decision Date | August 29, 2013 |
| Days to Decision | 87 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 |