K913890 is an FDA 510(k) clearance for the SONICATH(TM) 3.5 F, 20 MHZ. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on November 9, 1992, 438 days after receiving the submission on August 29, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K913890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1991 |
| Decision Date | November 09, 1992 |
| Days to Decision | 438 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 |