K030487 is an FDA 510(k) clearance for the R 72. This device is classified as a Device, Beam Limiting, X-ray, Diagnostic (Class II - Special Controls, product code KPW).
Submitted by Ralco S.R.L. (Deerfield, US). The FDA issued a Cleared decision on August 1, 2003, 168 days after receiving the submission on February 14, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1610.
| 510(k) Number | K030487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2003 |
| Decision Date | August 01, 2003 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPW — Device, Beam Limiting, X-ray, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1610 |