K031148 is an FDA 510(k) clearance for the IN-VISION IMAGING SYSTEM. This device is classified as a Echocardiograph (Class II - Special Controls, product code DXK).
Submitted by Jomed, Inc. (Rancho Cordova,, US). The FDA issued a Cleared decision on May 28, 2003, 48 days after receiving the submission on April 10, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2330.
| 510(k) Number | K031148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2003 |
| Decision Date | May 28, 2003 |
| Days to Decision | 48 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXK — Echocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2330 |