K072541 is an FDA 510(k) clearance for the SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on September 25, 2007, 15 days after receiving the submission on September 10, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K072541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2007 |
| Decision Date | September 25, 2007 |
| Days to Decision | 15 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 |