K110746 is an FDA 510(k) clearance for the 4D LV-ANALYSIS 3.0. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Tomtec Imaging Systems GmbH (Unterschleissheim, DE). The FDA issued a Cleared decision on May 24, 2011, 68 days after receiving the submission on March 17, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K110746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2011 |
| Decision Date | May 24, 2011 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | DQK - Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |