K911767 is an FDA 510(k) clearance for the ACUSON V510 TRANSDUCER. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on October 31, 1991, 195 days after receiving the submission on April 19, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K911767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1991 |
| Decision Date | October 31, 1991 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |