K864136 is an FDA 510(k) clearance for the 260SL IMAGING SYSTEM SMALL PARTS PROBES. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on January 27, 1987, 98 days after receiving the submission on October 21, 1986.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K864136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1986 |
| Decision Date | January 27, 1987 |
| Days to Decision | 98 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 |