K122921 is an FDA 510(k) clearance for the C1-6-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 October 5, 2012, 11 days after receiving the submission on September 24, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K122921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2012 |
| Decision Date | October 05, 2012 |
| Days to Decision | 11 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 |