K122515 is an FDA 510(k) clearance for the C2-9-D ULTRASOUND TRANSDUCER. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on September 11, 2012, 25 days after receiving the submission on August 17, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K122515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2012 |
| Decision Date | September 11, 2012 |
| Days to Decision | 25 days |
| Submission Type | Special |
| 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 |