K855247 is an FDA 510(k) clearance for the INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on February 19, 1987, 423 days after receiving the submission on December 23, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K855247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1985 |
| Decision Date | February 19, 1987 |
| Days to Decision | 423 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | ITX - Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |