K860620 is an FDA 510(k) clearance for the SHAMPAINE RADI-OP MODEL 1700RC. This device is classified as a Table, Radiologic (Class II - Special Controls, product code KXJ).
Submitted by Smith & Nephew, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 8, 1986, 48 days after receiving the submission on February 19, 1986.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K860620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1986 |
| Decision Date | April 08, 1986 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | KXJ — Table, Radiologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |