K103782 is an FDA 510(k) clearance for the 4D MV-ASSESSMENT 2.0. 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 January 27, 2011, 31 days after receiving the submission on December 27, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K103782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2010 |
| Decision Date | January 27, 2011 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQK - Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |