K071289 is an FDA 510(k) clearance for the ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Shimadzu Medical Systems (Torrance, US). The FDA issued a Cleared decision on January 9, 2008, 246 days after receiving the submission on May 8, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K071289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2007 |
| Decision Date | January 09, 2008 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |